FDA granted full approval of venetoclax (Venclexta, Genentech) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC)to treat acute myeloid leukemia (AML).

Venclexta, specifically designated to treat newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy, was previously granted provisional approval under FDA’s accelerated approval program in late 2018.

“Today’s full approval is supported by the significant results that showed that Venclexta in combination with azacitidine extended overall survival for people with newly diagnosed acute myeloid leukemia who cannot tolerate intensive induction chemotherapy,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development for at Genentech, in a 

“We are very pleased that this application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this treatment option more rapidly to patients in the United States and other countries,” Garraway added.

The approval is primarily based on the results of two Phase 3 studies. Results of the VIALE-A study showed Venclexta plus azacitidine significantly reduced the risk of death by 34% compared to azacitidine alone (the median overall survival was 14.7 months vs. 9.6 months).

 FDA approves new indication for leukemia drug

In addition, patients receiving Venclexta plus azacitidine had significantly higher rates of complete remission (CR) with 37% compared to 18% in people treated with azacitidine alone.

“Based on the results of this study, this treatment regimen represents a significant advance for older AML patients, including higher response rates, greater transfusion independence, longer durations of remission, and ultimately significantly improved overall survival compared to azacitidine alone,” said Courtney DiNardo, Md, associate professor of the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.

The National Comprehensive Cancer Network (NCCN) guidelines recently recommended Venclexta plus azacitidine as a Category 1 Preferred AML treatment regimen for patients ineligible for intensive chemotherapy, Genentech said.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the U.S. and commercialized by AbbVie outside of the country.

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Venclexta was previously granted provisional approval by FDA in late 2018.

FDA grants full approval for combination leukemia treatment

While President Donald Trump was optimistic that a COVID-19 vaccine would be ready prior to the presidential election, Pfizer says its vaccine candidate with partner BioNTech will likely be ready in late November.

“In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine,” wrote Pfizer Chairman and CEO Albert Bourla in an 

. “Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. “

U.S. government, AstraZeneca team up on COVID-19 preventative med

Pfizer will apply for EUA soon after the safety milestone is achieved in the third week of November, Bourla wrote.

“All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency,” he wrote.

Meanwhile, Moderna's COVID-19 vaccine could receive FDA EUA in December, if the company obtains positive interim results in November, 

If positive interim results from a large clinical trial take longer to get, the EUA may not occur until early next year, Chief Executive Stéphane Bancel said during 

U.S. gov’t, Abbott team up to produce millions of rapid COVID-19 tests

In addition, Pfizer received FDA approval to enroll children as young as 12 years old in its COVID-19 vaccine trial, NPR 

Until now, children under 16 have not been included in any COVID-19 vaccine trials in the U.S., NPR said.

Meanwhile, Bourla explained that Pfizer and BioNTech may know wether their vaccine is safe and effective by the end of October. “To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates,” he noted.

U.S. government secures remdesevir supply for COVID-19 patients

The pharma maker plans to apply for FDA Emergency Use Authorization for the vaccine after the third week of November.

Pfizer: COVID-19 vaccine likely ready late November

The United States government and AstraZeneca are teaming up to develop and produce the pharma maker’s preventive COVID-19 treatment.

U.S. Department of Health and Human Services (HHS) and the Department of Defense is partnering with AstraZeneca for late-stage development and large-scale manufacturing of the pharma maker’s COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies that may help treat or prevent infection with SARS-CoV-2, HHS said in a 

FDA expands emergency use authorization for remdesevir to include all hospitalized COVID-19 patients

“An effective monoclonal antibody that can prevent COVID-19, particularly one that is long-lasting and delivered by intramuscular injection, may be of particular use in certain groups,” HHS said. “This includes people who have compromised immune function, those who are over 80 years old, and people undergoing medical treatments that preclude them from receiving a COVID-19 vaccine.”

Notably, If FDA authorizes use of AZD7442 for prevention of SARS-CoV-2, the federal government will distribute the doses at no cost. Howerver, “as is customary with government-purchased medical products, healthcare professionals could charge for the cost of administering the product,” HHS said.

The Biomedical Advanced Research and Development Authority (

), part of the HHS Office of the Assistant Secretary for Preparedness and Response, and the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command will provide around $486 million to AstraZeneca for clinical trials and related development activities, including a large-scale manufacturing demonstration project and supply of AZD7442 doses in the U.S.

AstraZeneca estimates 100,000 doses of AZD 7442 could be available for the high-risk population that may not benefit from a vaccine by December 2020.

"In addition to Operation Warp Speed's historic progress on vaccines, we are supporting promising monoclonal antibodies for prevention and treatment all the way through to supply, allowing faster distribution if trials are successful," said HHS Secretary Alex Azar.

One of the Phase 3 clinical trials of AZD7442 will evaluate safety and efficacy of the product to prevent infection for up to 12 months in approximately 5,000 volunteers. An additional Phase 3 clinical study will evaluate if AZD7442 can help prevent infection in people who have come in contact with someone with COVID-19 in a post-exposure prophylaxis setting.

The pharma maker aims to make the treatment available to the most vulnerable populations by December.

US government, AstraZeneca team up on COVID-19 preventative med

FDA expanded the indication for the rheumatoid arthritis (RA) medication golimumab (Simponi Aria, Janssen) to treat patients 2 years and older with active polyarticular juvenile Idiopathic arthritis (pJIA) and psoriatic arthritis (PsA).

Simponi Aria is already approved Ito treat adults with moderately to severely active RA, active PsA, and active ankylosing spondylitis (AS).

Another RA drug starts testing to treat COVID-19

“This latest FDA approval of Simponi Aria for pediatric use in active pJIA and active PsA not only brings a new option to young patients living with these diseases but also adds to the growing body of evidence for this treatment,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development at Johnson & Johnson, in a 

“For far too long, children with pJIA or PsA have had limited treatment options,” said Seth D. Ginsberg, co-founder and president of the Global Healthy Living Foundation and CreakyJoints. “This approval represents an important step forward for these children and their families.”

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The approval was based on results from the GO-VIVA Phase 3 clinical trial, an open-label study in children with JIA with active polyarthritis. The children, ages 2 to 17 years old, had active arthritis in five or more joints despite receiving treatment with methotrexate for at least 2 months.

Trial results demonstrated that Simponi Aria was generally consistent with responses in adult patients with RA.

Simponi Aria is a fully human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of human TNFalpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation.

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Simponi Aria is now approved to to treat patients 2 years and older with active polyarticular juvenile Idiopathic arthritis (pJIA) and psoriatic arthritis (PsA).

RA drug indication expanded to other pediatric autoimmune disorders

FDA cleared the first treatment for mesothelioma in 16 years: nivolumab (Opdivo) in combination with ipilimumab (Yervoy).

The Bristol-Myers Squibb medication is for adults with malignant pleural mesothelioma that cannot be removed by surgery.

The approval “provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a 

FDA okays novel breast, colorectal cancer treatments

Malignant pleural mesothelioma is a rare cancer with limited treatment options, said study investigator Anne S. Tsao, MD, professor, section chief of Thoracic Medical Oncology, and director of the Mesothelioma Program at The University of Texas M.D. Anderson Cancer Center, in a Bristol-Myers Squibb 

“When it is diagnosed in advanced stages, the five-year survival rate is approximately 10%. The survival results from the CheckMate-743 trial show that the combination of nivolumab and ipilimumab could become a new front-line standard of care option.”

This is the third indication for an Opdivo plus Yervoy combination in the first-line treatment of a form of thoracic cancer.

The combination is also approved by FDA as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) and in combination with limited chemotherapy for the first-line treatment of adult patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations regardless of PD-L1 expression.

Opdivo plus Yevoy was evaluated during a randomized, open-label trial in 605 patients with previously untreated unresectable MPM. Patients who received the combination treatment survived a median of 18.1 months, while patients who underwent chemotherapy survived a median of 14.1 months.

At two years, 41% of patients treated with Opdivo and Yervoy were alive, compared to 27% with chemotherapy.

Pharma maker seeks fast approval of lymphoma treatment

The combination therapy of Opdivo plus Yervoy will treat the cancer caused by inhaling asbestos fibers.



FDA clears first treatment for mesothelioma in 16 years

A pharma maker is expanding its earlier recall of metformin due to a higher content of the carcinogenic ingredient N-Nitrosodimethylamine (NDMA) than is allowed.

Marksans Pharma Limited in India is voluntarily expanding its earlier initiated recall in June to include an additional 76 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg. and 750 mg. to the consumer level.

Sun Pharma recalls 1 lot of metformin due to NDMA levels

“Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96 ng/day. Therefore, out of an abundance of caution, an additional 76 lots are being recalled,” the pharma maker said in a 

 in recent months due to the presence of NDMA. FDA said in a 

 in June that its testing found “certain extended release metformin products contain NDMA above the acceptable level.”

 1 lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg. per 5 mL to the consumer level.

Another pharma maker recalls metformin over NDMA

In the Marksans recall, the recalled metformin was distributed by Time-Cap Labs in New York, nationwide to wholesalers that further distributed the medication to pharmacies.

Marksans is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement of recalled product lots.

The recall is attributed to higher levels of the carcinogenic ingredient NDMA than are allowed.

Metformin recalls expand

Pfizer snagged its fourth indication for the blockbuster medication tofacitinib (Xeljanz) for children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).

Xeljanz is already approved to treat adults with moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, adults with active psoriatic arthritis (PsA) after disease modifying 

 drug (DMARD) failure, and adults with moderately to severely active ulcerative colitis (UC) after tumor necrosis factor inhibitor (TNFi) failure.

Now, Xeljanz is the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA, Pfizer said in a press release.

The FDA approved 2 formulations of the medication: a tablet and an oral solution, which Pfizer expects be available by the end of the first quarter of 2021. However, the 5 mg. tablets are available immediately.

“Polyarticular course juvenile idiopathic arthritis, or pcJIA, is debilitating as it can cause significant joint pain and limit participation in child appropriate activities,” said Dr. Hermine Brunner, director of the Division of Rheumatology at Cincinnati Children’s Hospital Medical Center and scientific director of the Pediatric Rheumatology Collaborative Study Group.

“Although there are already several advanced treatments available, tofacitinib will be an appealing new option given it does not require injections or infusions. These can be quite burdensome to both children with pcJIA and their caretakers,” Brunner said.

Pfizer snags fourth indication for blockbuster Xeljanz

The FDA is requiring an update to the Boxed Warning on all benzodiazepines and new labeling that includes the medications’ risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions.

“Benzodiazepines can be an important treatment option for treating disorders for which these drugs are indicated. However, even when taken at recommended dosages, their use can lead to misuse, abuse, and addiction,” FDA said in its 

Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs, FDA added.

FDA is also warning that physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed. “Stopping them abruptly or reducing the dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening,” the agency said.

In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies. Alprazolam (Xanax) was the most commonly prescribed in the class at 38%, followed by clonazepam (Klonopin) at 24%, and lorazepam (Ativan) at 20%.

“We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence,” said FDA Commissioner Stephen M. Hahn, MD, in a 

In addition to requiring an update to the Boxed Warning, the FDA is requiring other changes to the Warnings and Precautions, Drug Abuse and Dependence and Patient Counseling Information sections of the prescribing information for all benzodiazepine products.

The agency is also requiring revisions to the existing patient Medication Guides for these medicines to help educate patients and caregivers about the risks.

FDA issues warning for certain hepatitis C drugs

Xanax and Ativan are among the medications impacted by FDA’s new requirements.

FDA requires new boxed warning on benzodiazepines

Sun Pharmaceuticals announced it is voluntarily recalling 1 lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg per 5 mL to the consumer level, according to a company statement.

The recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake limit established by the FDA.

When reconstituted, metformin hydrochloride for ER oral suspension is packaged in a 16 oz (473 mL) round bottle. Each carton contains 1 bottle of drug pellets, 1 bottle of diluent, and 1 dosing up. The products can be identified by the bottles or carton labeled with the lot number AB06381, with an expiration date of October 2021.

Sun Pharmaceuticals is notifying its distributors and customers through its third-party Recall Coordinator, via FedEx standard overnight shipping, and will arrange for return of all recalled products.

Patients taking metformin hydrochloride for ER oral suspension, 500 mg per 5 mL, are advised to continue taking their medication and contact their pharmacist, physician, or medial provider for advice regarding an alternative treatment.

 including details about metformin products that have been recalled. According to the FDA, its testing has not shown NDMA in immediate-release metformin products.

Sun Pharmaceuticals issued a voluntary recall of 1 lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg per 5 mL.


Sun Pharma Recalls 1 Lot of Metformin Due to NDMA Levels

While approval of several drugs have been delayed due to COVID-19, FDA has still cleared more than 30 new drugs this year — ahead of its average rate, a new OptumRx report says.

Here are the top 5 drugs in the pipeline for 2020 — either approved recently or expected to garner FDA clearance this year — according to OptumRx’s most recent Drug Pipeline Insight Report.

 Valoctocogene roxaparvovec (Roctavian, BioMarin) to treat hemophilia A in adults. While an FDA decision on whether or not the approve the medication was expected by August 21, the agency requested additional data from BioMarin.

Top 3 drugs to watch in second half of 2020

“Existing treatments for this condition are extremely expensive, costing up to $500,000 per year. Valoctocogene roxaparvovec would offer a one-time gene therapy that could replace the need for these treatments in some patients,” OptumRx wrote.

The projected wholesale acquisition cost (WAC) for valoctocogene roxaparvovec is expected to be in the range of $2 million to $3 million per one-time dose.

 Filgotinib (Jyseleca, Gilead Sciences) to treat moderate-to-severe rheumatoid arthritis (RA). The drug has yet to obtain FDA approval.

“Just one day prior the scheduled decision date, the FDA announced that it will require additional data from two ongoing safety studies of the drug. Relatedly, the FDA has expressed concerns regarding the overall benefit/risk profile of filgotinib at the 200 mg. dose used in trials,” OptumRx wrote. “Industry analysts speculate that if these concerns cannot be satisfied, the entire development program may be dropped by the manufacturer.”

 Brexucabtagene autoleucel (Tecartus, Kite, a Gilead company) treats adult patients with relapsed or refractory mantle cell lymphoma (MCL), a rare and aggressive form of non-Hodgkin’s lymphoma (NHL). It was approved in late July.

Notably, Tecartus is a chimeric antigen receptor T-cell (CAR T) therapy, which leverages and strengthens the power of a patient’s immune system to attack cancer cells.

FDA clears first cell-based gene therapy for lymphoma

“Tecartus becomes the first CAR T-cell therapy for MCL, offering an additional treatment option for patients with relapsed or refractory MCL that only requires a one-time dose administered by IV infusion,” OptumRx wrote.

In trials with a median follow-up period of 12.3 months, 93% of patients responded to a single infusion of Tecartus, including 67% of patients who achieved a complete response.

 Subcutaneous ofatumumab (Kesimpta, Novartis), approved in late August, treats relapsing forms of multiple sclerosis (MS). Ofatumumab is currently available in intravenous (IV) form as Arzerra, which is FDA approved for the treatment of chronic lymphocytic leukemia.

Kesimpta will be entering a crowded MS marketplace, competing not only with Aubagio, but also with other well established oral and injectable products with different mechanisms of action, OptumRx said.

“Analysts say that being self-administered by subcutaneous injection would give Kesimpta a key advantage,” OptumRx said.

 Tafasitamab-cxix (Monjuvi, MorphoSys AG), approved in late July, is the first FDA-approved, second-line regimen for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Monjuvi is to be used in combination with lenalidomide (Revlimid). It will be competing with polatuzumab vedotin (Polivy), which was approved in June 2019 for a similar indication.

Some of the top medications were approved this summer, while others are awaiting FDA approval.