Merck’s Keytruda/chemotherapy combo treatment demonstrates a statistically significant and clinically meaningful improvement in overall survival (OS) for patients with triple-negative breast cancer (mTNBC), according to recent data.

The phase 3 KEYNOTE-355 study of Keytruda (pembrolizumab) in combination with chemotherapy (paclitaxel, nab-paclitaxel or gemcitabine/carboplatin) reduced the risk of death by 27% in patients with mTNBC whose tumors expressed PD-L1 compared with chemotherapy alone, Merck said in a 

There was an increase of 6.9 months in median overall survival with Keytruda plus chemotherapy compared with chemotherapy alone (23 months versus 16 months). The increase in overall survival was observed across the three chemotherapy choices.

European Society for Medical Oncology (ESMO) Congress 2021

currently approved under accelerated approval

 in the United States in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1.

“Metastatic TNBC has the worst survival prognosis among breast cancer subtypes, and there is an urgent need for treatment options that improve survival,” Hope Rugo, M.D., director, Breast Oncology and Clinical Trials Education, University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, said in a statement. “I am very encouraged to see these new overall survival data for the Keytruda combination.”

“With these new data, KEYNOTE-355 has now met both primary endpoints, improving progression-free and overall survival for the approximately 40% of patients from this trial with metastatic TNBC whose tumors expressed PD-L1,” Vicki Goodman, M.D., vice president, clinical research, Merck Research Laboratories, said in a statement.

The incidence of treatment-related adverse events was similar among patients in the two treatment groups, with Grade 3 to 5 adverse events occurring in 68% of patients in the Keytruda plus chemotherapy arm and nearly 67% of patients in the chemotherapy arm. Treatment-related adverse events led to discontinuation in 18.3% of patients in the Keytruda plus chemotherapy arm and 11% of patients in the chemotherapy arm.

Triple-negative breast cancer is a type of breast cancer that tests negative for estrogen hormone receptors, progesterone hormone receptors, and overexpression of human epidermal growth factor receptor 2. It is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. About 10% to 15% of patients with breast cancer are diagnosed with TNBC, which tends to be more common in people who are younger than 40 years of age, who are African American, or who have a 

Articles

Keytruda plus chemotherapy reduces the risk of death by 27% in patients with triple-negative breast cancer.

Merck Shares Significant Keytruda Breast Cancer Results

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

 the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for use of a single booster dose for:

People through 64 years of age at high risk of severe COVID-19; and

People 18 through 64 years of age at risk for occupational exposure to COVID-19.

The FDA authorized the booster to be given at least six months after completion of the primary vaccination.

“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” Acting FDA Commissioner Janet Woodcock, M.D., said in a statement.

This authorization comes less than a week after the FDA’s Vaccines and Related Biological Products Advisory Committee voted 16-2 against full approval for the use of Pfizer’s vaccine, now called Comirnaty, in people over the age of 16. But they did vote unanimously to provide an emergency use authorization of the vaccine as a booster after six months for those over the age of 65 and those at high risk of severe COVID-19.

Read more about the committee’s decision

Pfizer and BioNTech continue to supply the vaccine under their existing 

 with the U.S. government, which continues through April 2022. Executives from the companies do not expect the introduction of booster doses in the United States to impact the existing supply agreements in place with governments and international health organizations.

We will continue to monitor new SARS-CoV-2 strains, to be prepared for potential emerging escape variants,” Ugur Sahin, M.D., CEO and co-founder of BioNTech, said in a statement. “We and our collaboration partner have submitted booster data to other regulatory agencies around the world. We are simultaneously working to expand access to our vaccines globally.”

The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the use and rollout of boosters.


People over the age 65 and those at high risk of severe COVID-19, including health care workers and those with occupational exposure, are eligible for the booster. 


FDA Issues EUA for Booster of Pfizer’s COVID-19 Vaccine

Par Pharmaceutical, part of Endo International, has 

 the generic version of Pfizer's Chantix (varenicline), 0.5 mg and 1 mg tablets. Developed by Par Pharmaceutical, which is part of Endo International, the generic varenicline tablet was approved by the FDA August 11, 2021.

 all remaining lots of Chantix due to the presence of a nitrosamine, N-nitroso-varenicline, which may be associated with a potential increased cancer risk in humans.

Dr. Reddy’s launches generic of Librax.

 chlordiazepoxide hydrochloride and clidinium bromide

capsules, a generic version of Librax (chlordiazepoxide hydrochloride and clidinium bromide). It is approved to treat gastrointestinal disorders, such as peptic ulcer, irritable bowel syndrome (irritable colon, spastic colon, mucous colitis), and acute enterocolitis. It is available in one strength of 5 mg/2.5 mg capsules in bottle count sizes of 100.

FDA approves generic clindamycin phosphate foam.

 FDA approval for clindamycin phosphate foam, 1%, the generic version of Mylan’s Evoclin Foam, 1%, an antibiotic that is used to treat acne.

According to IQVIA sales data for the 12-month period ending July 2021, the Evoclin Foam, 1%, market achieved annual sales of about $12.0 million

 the abbreviated new drug application of Milla Pharmaceuticals’ generic version of sodium acetate injection 2 MEQ/mL as a source of sodium as an addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also used as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

The company, a subsidiary of the Alter Pharma Group, has announced that it has launched this product.

Milla Pharmaceuticals has established its first commercial sale through its exclusive partner, Woodward Pharma Services, and has secured 180-days of market exclusivity. The FDA has recently 

 sodium acetate Injection 2MEQ/mL on their its drug shortages list.

Dr. Reddy’s has also launched a generic of Librax. Recent generic approvals include clindamycin phosphate foam and sodium acetate.

Par Launches Generic of Smoking Cessation Drug Chantix

 Incyte’s Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies. Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States. Research shows dysregulation of the JAK-STAT pathway contributes to key features of atopic dermatitis such as itch, inflammation, and skin barrier dysfunction.

The FDA approval was based on data from two phase 3 studies (TRuE-AD1 and TRuE-AD 2) evaluating the safety and efficacy of Opzelura in more than 1,200 adolescents and adults. Results from the studies showed patients experienced significantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily, compared with a non-medicated cream. Significantly more patients treated with Opzelura experienced a clinically meaningful reduction in itch from baseline at Week 8.

The most common adverse reactions were nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, and tonsillitis.

“Atopic dermatitis is a chronic immune-mediated disease that can be challenging to manage. Many patients do not respond well to existing treatments and have uncontrolled disease,” Jonathan Silverberg, M.D., Ph.D., M.P.H., associate professor of dermatology and director of clinical research and contact dermatitis at The George Washington University School of Medicine and Health Sciences, said in a statement.

Opzelura is a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib.

Atopic dermatitis is a chronic skin disease affecting more than 21 million people aged 12 years and older in the United States and is characterized by inflammation and itch.

Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States. 

FDA Approves Topical JAK inhibitor for Atopic Dermatitis

 to Genmab/Seagen’s Tivdak (tisotumab vedotin-tftv), the first approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tivdak is approved under the FDA’s Accelerated Approval Program based on tumor response and the durability of the response. Approval is contingent upon confirmatory trials.

The approval is based on the phase 2 innovaTV 204 trial, which evaluated 101 patients. Results from the trial showed a 24% objective response rate, and the median duration of response was 8.3 months.

The most common adverse reactions were hemoglobin decreased (52%), fatigue (50%), lymphocytes decreased (42%), nausea (41%), peripheral neuropathy (39%), alopecia (39%), epistaxis (39%), conjunctival adverse reactions (37%), hemorrhage (32%), and leukocytes decreased (30%).

These data were featured in a late-breaking proffered paper oral presentation at 

 in April 2021. A global, randomized phase 3 clinical trial (innovaTV 301) is under way and is intended to support global registrations.

“Once recurrent or metastatic cervical cancer progresses, there is a need for more options for these patients,” Robert L. Coleman, M.D., chief scientific officer, US Oncology Research and lead investigator of the innovaTV 204 clinical trial, said in a statement. “This is an important development for patients with recurrent or metastatic cervical cancer.”

Tivdak is an ADC composed of Genmab’s human monoclonal antibody directed to tissue factor and Seagen’s ADC technology that uses a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E to the antibody. Nonclinical data suggests that the anticancer activity of the therapy is due to the binding of the ADC to tissue factor-expressing cancer cells.

In 2018, there were an estimated 293,394 women living with cervical cancer in the United States. The National Institutes of Health 

 there will be an additional 14,480 cases this year and an estimated 4,290 deaths from cervical cancer.

Tivdak is the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer.

FDA Approves Tivdak for Advanced Cervical Cancer

 for filing Marinus Pharmaceuticals’ new drug application (NDA) for the use of ganaxolone in the treatment of seizures associated with CDKL5 deficiency disorder, a rare, genetic epilepsy. The NDA was granted Priority Review designation and the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of March 20, 2022.

The application is supported by data from the Marigold study, a phase 3 trial in 101 patients. Patients treated with ganaxolone showed a 30.7% median reduction in 28-day major motor seizure frequency, compared with a 6.9% reduction for those receiving placebo. Patients in the open-label extension study treated with ganaxolone for at least 12 months experienced a median 49.6% reduction in major motor seizure frequency.

Ganaxolone received orphan drug designation in 

 and a Rare Pediatric Disease designation for CDKL5 deficiency disorder in 

“The FDA’s acceptance of our NDA submission is an important step toward potentially bringing the first approved therapy specifically for treatment of seizures associated with CDD—a devastating disorder with high unmet medical need—to families and healthcare providers,” Scott Braunstein, M.D., chief executive officer of Marinus Pharmaceuticals, said in a statement. “We believe that ganaxolone has the potential to provide meaningful clinical benefit for patients and we look forward to working closely with the FDA during the review process.”

 that is caused by a mutation of the cyclin‑dependent kinase‑like 5 (CDKL5) gene, located on the X chromosome. CDKL5 deficiency disorder is characterized by early‑onset, difficult‑to‑control seizures and severe neuro‑developmental impairment. Currently, there are no therapies approved specifically for CDD. The incidence 1 in 40,000 to 60,000 newborns. About 90% of those diagnosed with CDKL5 deficiency disorder are girls.

The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.


FDA has Accepted Application for Rare Epilepsy

 to the FDA seeking approval for Skyrizi (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate-to-severe Crohn’s disease. Approval is being sought for both the 600 mg intravenous induction and 360 mg subcutaneous maintenance therapy.

The submission is supported by safety and efficacy data from three phase 3 studies – ADVANCE, MOTIVATE and FORTIFY. In these trials, Skyrizi demonstrated improvements in clinical remission and endoscopic response as both induction and maintenance therapy. The overall safety findings in these studies were consistent with previous studies.

In the FORTIFY study, a significantly greater proportion of participants achieved the co-primary end points of endoscopic response and clinical remission with Skyrizi subcutaneous maintenance therapy at one year (52 weeks) for both assessed doses (360 mg or 180 mg), compared with those who were randomized to the withdrawal arm and received placebo. 

In the ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients with Crohn's disease treated with either dose of Skyrizi IV induction therapy (600 mg or 1200 mg) met the co-primary end points of clinical remission and endoscopic response at week 12 compared with placebo.

“While there have been advancements in care, many people with Crohn's disease do not achieve lasting remission,” Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie, said in a statement.

In April 2019, the FDA approved Skyrizi for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Phase 3 trials of Skyrizi in psoriatic arthritis, Crohn's disease, and ulcerative colitis are ongoing.

 is a chronic disorder that primarily affects the digestive system. This condition involves an abnormal immune response that causes excess inflammation. It most often affects the intestinal walls, particularly in the lower part of the small intestine and portions of the large intestine. Crohn’s disease is most common in western Europe and North America, where it has a prevalence of 100 to 300 per 100,000 people. More than half a million Americans are currently affected by this disorder.

In trials, Skyrizi demonstrated improvements in clinical remission and endoscopic response as both induction and maintenance therapy

AbbVie Submits Skyrisi to FDA for Crohn’s Disease

 priority review of the Biologics License Application (BLA) for the combination of relatlimab and Opdivo (nivolumab), administered as a single infusion, for the treatment of adult and adolescents with unresectable or metastatic melanoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.

The BLA submission was based on the efficacy and safety results of the phase 2/3 RELATIVITY-047 trial, which demonstrated that the combination therapy achieved progression-free survival benefit of 10.1 months compared with 4.6 months for Opdivo alone.

“We believe that the relatlimab and nivolumab fixed-dose combination has the potential to improve outcomes for patients with metastatic or unresectable melanoma,” Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb, said in a statement.

Relatlimab is the first LAG-3-blocking antibody to demonstrate a clinical benefit for patients with phase 3 data. Primary results from the RELATIVITY-047 trial were 

 during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2021. Adverse events leading to discontinuation of treatment in 14.6% of patient receiving the combination therapy versus 6.7% for those receiving Opdivo alone.

Lymphocyte-activation gene 3 (LAG-3) functions to control T-cell response, activation, and growth.

Melanoma is the fifth most common cancer, 

 to the National Institutes of Health. The NIH estimates that in 2021 more than 7,000 people will die from melanoma.

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.

FDA Accepts BMS Application for Opdivo/Relatimab Combination for Advanced Melanoma

 Biogen and Samsung Bioepis’ Byooviz (ranibizumab-nuna) as the first biosimilar to Genentech’s Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration, a leading cause of vision loss and blindness for Americans over the age of 65. Byooviz is also approved to treat macular edema following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness).

Byooviz is an anti-vascular endothelial growth factor (VEGF) therapy that prevents vision loss in patients with retinal vascular disorders, which can cause irreversible blindness or visual impairments in adults in the United States.

The FDA approval of Byooviz was based on a totality of evidence including analytical, nonclinical data, and clinical data. In a phase 3 study, the efficacy, safety, pharmacokinetics, and immunogenicity of Byooviz was compared with Lucentis in patients with wet AMD.

“Today’s approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products,” Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement.

There are two types of AMD—dry and wet. While dry AMD is more common, wet AMD leads to vision loss at a faster rate. Both macular edema and myopic choroidal neovascularization can also lead to visual impairment. About 11 million people 

 with AMD in the United States alone, with a global prevalence of 170 million.

Byooviz was approved in the European Union (EU) on August 18, 2021, and the United Kingdom on August 31, 2021.

BYOOVIZ is Samsung Bioepis’ fifth biosimilar approved in the United States, following the approval of Renflexis (infliximab-abda), a biosimilar of Remicade approved in April 2017 to treat several autoimmune diseases including Crohn’s and rheumatoid, Ontruzant (trastuzumab-dttb), a biosimilar of Herceptin approved in January 2019 to treat HER2-positive breast and gastric cancer, Eticovo (etanercept-ykro), a biosimilar of Enbrel approved in April 2019 to treat arthritis and plaque psoriasis, and Hadlima (adalimumab-bwwd), a biosimilar of Humira approved in July 2019 to treat arthritis and psoriasis.

Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis. 

FDA Approves First Biosimilar to Treat Macular Degeneration 

The Centers for Medicare & Medicaid Services (CMS) 

 a permanent J-code (J2406) for Melinta Therapeutics’ Kimyrsa (oritavancin), a lipoglycopeptide antibiotic, effective October 1, 2021. This code allows the product to be reimbursed when dispensed in the outpatient setting. Kimyrsa is approved to treat acute bacterial skin and skin structure infections in a single, one-hour, 1,200 mg infusion. The FDA approved the therapy on March 12, 2021, for the treatment of adult patients with Gram-positive infections, including methicillin-resistant Staphylococcus aureus (MRSA).

At the same time, CMS has granted transitional pass-through status for Kimyrsa in the hospital outpatient department setting. Pass-through status is intended to protect Medicare beneficiaries’ access to innovative drugs and ensures that Kimyrsa will be reimbursed at average sales price for three years. Drugs with pass-through status are not subject to the payment reduction applicable to drugs purchased through the 340B program.

“We intentionally designed Kimyrsa to provide patients with more flexibility and accessibility in acute bacterial skin and skin structure infection treatment. These achievements are one more significant step toward our vision that all patients who need our therapies will be able to receive them,” Christine Ann Miller, Melinta’s president and chief executive officer, said in a statement.

Bacterial skin and skin structure infections affect about 14 million patients in the United States each year.

Effective October 1, 2021, CMS will reimburse for the infusion product when dispensed in the outpatient setting.

CMS Assigns J-Code for the Antibiotic Kimyrsa 

Drug Shortages Update — September 26, 2021

Competition created by biosimilars has saved the U.S. health care system $9.8 billion over the past five years, according to a Amgen’s 

 Biosimilars are launching at a price that is generally 15% to 37% lower than the reference product, and uptake of biosimilars is increasing, the report finds.

“The increasing availability and adoption of biosimilars means these treatments are delivering on the fundamental promise of reducing health care costs for payers, employers, and patients in the United States,” Jennifer Norton, vice president, head of U.S. value and access at Amgen, said in 

Biosimilars for oncology therapeutics have seen strong growth. The five biosimilars of Herceptin (trastuzumab) and two biosimilars of Avastin (bevacizumab) account for nearly 70% of sales by volume. While the prices of all trastuzumab products have declined over time, biosimilar prices are now 24% to 45% lower than the reference product Herceptin’s average sales price. Two years after the first launch, the price of bevacizumab biosimilars is now 22% to 29% lower than the price of reference product Avastin.

The three biosimilars of Rituxan (rituximab) account for 55% of sales by volume. In less than two years after the first launch, the price of rituximab biosimilars is now 15% to 32% lower than the price of reference product.

In oncology supportive care, there are four biosimilars of Neulasta (pegfilgrastim). All four launched between a 33% to 37% discount to the reference product’s wholesale average cost. The two biosimilars to Neupogen (filgrastim), plus Granix (which was approved under a BLA before the biosimilar pathway was established, are now 56% to 64% lower than the reference product.

Other key takeaways from the report include:

Since the first biosimilar entered the U.S. marketplace in 2015, 30 products have been approved and 21 products have been launched.

The prices of biosimilars are decreasing at a compound annual growth rate of 9% to 19%. The prices of most reference products are decreasing at a compound annual growth rate of 4% to 17%.

Biosimilars have the potential to reduce out-of-pocket spending by $238 million for patients in the nine biologic drug classes where biosimilars have been approved.

Amgen’s Biosimilar Trend Report finds that biosimilars have been introduced at a price that is generally 15% to 37% lower than the reference product.




Report: Biosimilars Have Saved the Health Care System $9.8 Billion

Blue Cross Blue Shield plans in 2019 paid more for cancer therapies administered in hospital outpatient settings than for those given in physician offices, according to 

 published in Health Affairs this month. The plans could have saved $1.28 billion if those drugs were administered at the physicians’ offices.

“Plans paid 50% to 90% more in hospital outpatient departments than in freestanding physician offices for most of the drugs. The price differences for infused cancer drugs mirror price differences reported elsewhere for a wide range of health care services, including diagnostic tests, radiology, and ambulatory surgery,” investigators wrote.

Investigators used 2019 data from Blue Cross Blue Shield Axis, a claims database, to assess payment rates for cancer biologics, chemotherapies, and infused hormonal therapies for enrollees throughout the United States. They focused on the 38 most commonly infused cancer drugs, which accounted for about 80% of total Blue Cross Blue Shield spending for cancer therapies that year. Included were patients covered individually or through employer plans; Medicare and Medicaid beneficiaries were excluded.

Investigators found that across all 38 drugs, hospital outpatient department prices were twice as high as those paid by insurers in physician offices. For the 12 biologics that were assessed, hospital outpatient department prices ranged from a minimum of 54% to a maximum of 78% above physician office prices, with a median of 67%.

For chemotherapies, hospital outpatient departments were 72 percent and for which hospital outpatient department prices exceeded those in physician by as much as 182. Investigators noted there were three chemotherapies where prices charged for hospital outpatient were below those of physician offices.

Prices charged in hospital outpatient departments for hormonal therapies exceeded those charged in physician offices by a median of 87%.

Investigators estimated that a narrow-network strategy, which would deny coverage for hospital-based administration of these cancer drugs and would funnel patients instead to physician offices, would have generated savings to insurers of $1.28 billion in 2019.

The narrow-network strategy, investigators said, would limit cost sharing with patients, which could exceed amounts patients are able pay.

“The cancer drug price differences reported here, and in particular the high prices charged in hospital-based infusion clinics, reflect larger dynamics in the health care system,” investigators wrote.

Shifting cancer patients to the physician setting for administration of cancer therapies could save insurers $1.28 billion.

Study: Insurers Pay More for Cancer Therapies Administered in Hospital Setting

Onco360, an independent oncology pharmacy, has been selected by Takeda to be a specialty pharmacy partner for Exkivity (mobocertinib), the first oral treatment option for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Onco360 dispenses nationally through its network of URAC-, and ACHC-accredited oncology pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States.

The FDA approved Exkivity on September 15, 2021. Exkivity, which was granted priority review and received breakthrough therapy designation, fast track designation, and orphan drug designation from the FDA, is the second approval for this indication and the first approved oral therapy to target EGFR exon 20 insertion mutations.

This indication is approved under accelerated approval based on overall response rate and duration of response. The FDA approval is based on results from the platinum-pretreated population in the phase 1/2 trial of Exkivity in patients who had received prior platinum-based therapy. Results were presented at the 

2021 American Society of Clinical Oncology (ASCO) Annual Meeting

 In May. In this trial, the therapy demonstrated an overall response rate of 28% as well as a median duration of response of 17.5 months, a median overall survival of 24 months.

Related: FDA Approves Exkivity, a Novel Oral Therapy for Lung Cancer

Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations. 

Onco360 Chosen as a Specialty Pharmacy for Takeda’s Exkivity

disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

 that occurs when the graft's immune cells recognize the host as foreign and attack the recipient’s body cells. It can occur in up to half of patients receiving hematopoietic stem cell transplantation.

“In the United States, there are over 14,000 people living with chronic GVHD, many of whom face significant complications that may impair daily activities and linger for years,” Susan Stewart, executive director, BMT InfoNet, said in a statement. “The approval of Jakafi is an exciting development for the GVHD community and an important step forward in the treatment of a disease with few options.” The Blood & Marrow Transplant Information Network (BMT InfoNet) is a leading advocacy organization for bone marrow, stem cell and cord blood transplant patients.

The approval was based on the REACH3 study, a phase 3 study of Jakafi in comparison to best available therapy for treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation. The primary end point of overall response rate at week 24 was 49.7% for Jakafi compared with 25.6% for best available therapy. The most common nonhematologic adverse reactions (incidence ≥ 20%) were infections. Full results from the REACH3 study were 

This approval is the fourth FDA-approved indication for Jakafi, which received FDA-approval in 2019 for steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi outside the United States.

This is the fourth approval for Jakafi, a JAK1/JAK2 inhibitor.

Drug Shortages Update — September 26, 2021

Report: Biosimilars Have Saved the Health Care System $9.8 Billion

Study: Insurers Pay More for Cancer Therapies Administered in Hospital Setting

Onco360 Chosen as a Specialty Pharmacy for Takeda’s Exkivity

FDA Approves Jakafi for GVHD