Gilead’s Trodelvy (sacituzumab govitecan-hziy), received full FDA approval and an expanded indication for patients with advanced or metastatic triple-negative breast cancer (TNBC).

The FDA granted accelerated approval to Trodelvy a year ago, but the new approval expands the drug's indication to include treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

MacroGenics’ treatment for HER2-positive breast cancer to be available in March

The commercial list price or Trodelvy is around $2,100 per vial, a spokesperson told 

 The cost of therapy is dependent on patient weight and duration of treatment, the spokesperson said.

Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse, Gilead said in a 

. Prior Trodelvy’s approval, patients with previously treated metastatic TNBC had few treatment options, according to Gilead.

“Women with triple-negative breast cancer have historically had very few effective treatment options and faced a poor prognosis,” said Aditya Bardia, MD, MPH, director of Breast Cancer Research Program, Mass General Cancer Center; assistant professor of medicine at Harvard Medical School, and global principal investigator of the ASCENT study.“[FDA’s] approval reflects the statistically significant survival benefit seen in the landmark ASCENT study and positions sacituzumab govitecan-hziy as a potential standard of care for pre-treated TNBC.”

In the Phase 3 ASCENT study, Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS), extending median PFS to 4.8 months from 1.7 months with chemotherapy.

Trodelvy also extended median overall survival (OS) to 11.8 months versus 6.9 months, a 49% reduction in the risk of death.

Trodelvy carries a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea.

FDA okays novel breast, colorectal cancer treatments

Articles

The new approval expands the drug's indication to include treatment in adult patients with unresectable locally advanced or metastatic triple-negative breast cancer.

Gilead’s breast cancer treatment snags expanded indication

Two common antidepressant and antifungal drugs were very effective at inhibiting SARS-CoV-2, the virus that causes COVID-19, according to a new study.

Researchers found that the antifungal itraconazole (Sporanox, other brand names) and the antidepressant fluoxetine (Prozac), in combination with the antiviral drug remdesivir, inhibited the production of SARS-CoV-2 by more than 90%.

Merck’s experimental drug shows quick reduction in SARS-CoV-2

The study was published April 6 in. the 

Researchers tested the antiviral potential of itraconazole and fluoxetine on the production of infectious SARS‐CoV‐2 particles — alone and in combination with remdesivir — using a cell culture model in the lab.

Related: FDA authorizes new COVID-19 treatment, more vaccine doses on the way

Importantly, both the itraconazole–remdesivir and fluoxetine–remdesivir combinations displayed synergistic effects, as determined in commonly used reference models for drug interaction, wrote senior author Ursula Rescher, PhD, with the University of Muenster, Germany, and colleagues.

“Itraconazole–remdesivir and fluoxetine–remdesivir combinations are promising starting points for therapeutic options to control SARS‐CoV‐2 infection and severe progression of COVID‐19,” they wrote.

FDA okays first combo COVID-19 and flu test

Two common antidepressant and antifungal drugs were very effective at inhibiting SARS-CoV-2, the virus that causes COVID-19, according to a new study.









Prozac, antifungal drug inhibit SARS-CoV-2 in new study 

 extended-release capsules (Qelbree, Supernus Pharmaceuticals), its first drug approval for children with attention-deficit hyperactivity disorder (ADHD) in more than a decade.

The sprinkleable non-stimulant medication is indicated for pediatric patients 6 to 17 years old. “Capsules can be opened and sprinkled on a teaspoonful of applesauce or swallowed whole. This makes it easier for patients — like a young child — who might have difficulty swallowing a capsule whole,” Jack Khattar, president and CEO of Supernus, told 

FDA clears first non-drug option to treat ADHD in children

Based on the efficacy demonstrated in Supernus’s clinical trials, “We believe Qelbree offers a unique new alternative for the treatment of ADHD,” Khattar said in a 

 issued on April 2. “Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile.”

Khattar expects Qelbree to be available this quarter but declined to reveal the drug’s wholesale acquisition cost. “Supernus doesn’t comment on pricing of new products before they are launched,” Khattar said, adding that Qelbree will be priced comparably to other ADHD products in the market. “We plan to have a robust patient access program available at launch, including a copay assistance program,” Khattar said.

FDA approves Ponvoy, once-a-day oral drug for MS

Qelbree’s approval in based on data from an extensive development program consisting of four Phase 3 clinical trials that studied more than 1,000 pediatric patients, ages 6 to 17.

In December, Supernus announced positive results from a Phase 3 trial in adult patients with ADHD and plans to submit a supplemental New Drug Application to the FDA for Qelbree in adults in the second half of 2021.

Qelbree may increase suicidal thoughts and actions in some children with ADHD — especially within the first few months of treatment or when the dose is changed, Supernus said. Qelbree is also contraindicated for patients who also take certain antidepression medicines— especially monoamine oxidase inhibitors — or certain asthma medicines.

FDA clears first generic treatment for severe hypoglycemia

The novel nonstimulant medication from Supernus Pharmaceuticals can be sprinkled on food.


FDA clears Qelbree, first new ADHD drug for children in more than a decade

A pharmaceutical supplier is recalling a massive amount of acetaminophen tablets while a pharmaceutical manufacturer is recalling three lots of guanfacine, which is prescribed for attention deficit hyperactivity disorder (ADHD).

 Corp is recalling three lots of Guanfacine Extended-Release Tablets 2 mg to the consumer level due to trace amounts of quetiapine fumarate in one lot, labeled RX1663. “Out of an abundance of caution, lots RX1662 and RX1664 are also included in the scope of this voluntary recall as they were manufactured in the same campaign as lot RX1663,” Apotex said in a 

Quetiapine is indicated as a treatment of schizophrenia and other serious mental disorders such as bipolar disorder manic episodes, bipolar disorder and depressive episodes.

Administering Guanfacine Extended-Release Tablets containing trace amounts of Quetiapine Fumarate to a patient can result in the possibility of hypersensitivity reaction and could lower blood pressure and could cause sleepiness/sedation and dizziness, warned the company. “Pediatric patients, pregnant patients and older adults may be more likely to experience low blood pressure and dizziness if exposed to the defective product,” Apotex said in the press release

However, the pharma maker has not received any reports of adverse events related to the recall. The affected lots were distributed in the U.S. between December 22, 2020, and March 19, 2021.

Meanwhile, A-S Medication Solutions is voluntarily recalling 198,350 bottles of acetaminophen extra strength 500 mg. tablets, contained in Health Essentials Kits distributed by Humana to its members. 

The 100 ct. bottles, NDC# 50090-5350-0, were distributed nationwide between January 14, 2021, and March 15, 2021.

Sun Pharma recalls 1 lot of metformin due to NDMA levels

The recalled products contain an incomplete prescription drug label rather than the required OTC Drug Facts label, ASM said in a 

Use of acetaminophen could be potentially harmful if safety warnings in the label are not observed, including the risk of liver damage if consumers exceed the recommended dose, take acetaminophen with excessive consumption of alcohol or are allergic to the active ingredient, ASM said.

However, the company has not received any reports of adverse events related to the recall.

The 100-count bottles, NDC 50090-5350-0, are packaged in white plastic bottles contained in a clear plastic bag with other seasonal products labeled as a Health Essentials Kit. Expiration dates are either 7/31/22 or 8/31/22.

Companies recall large amount of guanfacine, acetaminophen

FDA cleared Bristol Myers Squibb and bluebird bio’s novel CAR-T cell therapy, Abecma (idecabtagene vicleucel; ide-cel). The treatment is the first B-cell maturation antigen (BCMA)-directed CAR-T cell immunotherapy for adults with relapsed or refractory multiple myeloma after 4 or more prior lines of therapy.

Abecma, a personalized immune cell therapy that features a one-time infusion with CAR-positive T cells, carries a wholesale acquisition cost of $419,500. The WAC recognizes “the clinical innovation Abecma represents while maintaining access and affordability,” a spokesperson told 

FDA clears BMS CART-T cell therapy, Merck MET inhibitor

A network has been created to support “rapid and dependable manufacturing of Abecma and ensure capacity to accommodate patient demand,” the pharma makers said in a 

. Abecma will be manufactured for each individual patient using their own T cells at BMS’s immunotherapy manufacturing facility in Summit, NJ.

BMS is working to onboard a network of certified treatment centers to begin treating patients with the CAR-T therapy. Treatment centers will be Risk Evaluation and Mitigation Strategy (REMS) certified to support appropriate use of Abecma, which is available only through the Abecma REMS program, the spokesperson said.

As an anti-BCMA CAR T cell therapy, Abecma recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells, BMS and bluebird bio said.

FDA clears first cell-based gene therapy for lymphoma

“CAR T cell therapies have shown transformational potential for the treatment of hematologic malignancies, and we, with our partners at bluebird bio, are proud to bring the first CAR T cell therapy to appropriate triple-class exposed patients with relapsed or refractory multiple myeloma, offering the chance for durable response,” said Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb.

FDA’s approval is based on data from the pivotal Phase 2 KarMMa trial of 127 patients with relapsed or refractory multiple myeloma who had received at least 3 prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

The overall response rate (ORR) for the efficacy evaluable population was 72% and 28% of patients achieved a stringent complete response (sCR). Responses were rapid and durable, with a median time to response of 30 days and median duration of response of 11 months for all responders and 19 months who achieved sCR.

Of the 28 patients who achieved sCR, an estimated 65% had remission lasting at least 12 months.

A conversation about real-world data with COTA’s Viraj Narayanan

Bristol Myers Squibb and bluebird bio’s Abecma is the first B-cell maturation antigen (BCMA)-directed CAR-T cell immunotherapy for relapsed or refractory multiple myeloma after 4 or more prior lines of therapy.

FDA okays first CAR-T cell therapy for a specific myeloma

Real-world clinical data is becoming increasingly important in clinical research trials, particularly in oncology. To that end, Kite Pharma, a Gilead Sciences company, is the latest pharmaceutical manufacturer to partner with COTA, an oncology real-world data and analytics company.

The Miami Cancer Institute, Novartis, BristolMyersSquibb, Hackensack Meridian Health, Regional Cancer Care Associates, and other manufacturers and cancer centers have also teamed up with COTA to obtain and supply RWD and other oncology clinical research trends.

, vice president of Life Sciences at COTA, to discuss the importance of real-world data.

Here is edited transcript of our conversation:

How did COVID-19 increase the importance of utilizing RWD for clinical research trials?

We are in the speed game of trying to accelerate drug development. With COVID-19, the collaboration between regulators, scientists, manufacturers, and the government in funding research forced society to look at drug development in a whole different way. And it is really difficult to argue that we didn’t have tremendous outcomes. COVID-19 vaccines were approved in record time. I genuinely feel like we are on a journey with regulators in terms of looking at new ways of doing things; we are going to look back at COVID-19 as a key accelerator.

Why is real-world data so important to pharmaceutical manufacturers at this time?

The crux of relevant clinical information is found outside of clinical trials: 3% of all cancer patient data is seen in clinical trials, while 97% of cancer patient data is seen in the real world, in their electronic medical records.

Within the last decade, with advances in precision medicine, many patients are getting treated in a more advanced way with biomarkers and CAR-T cell therapies. Cancer is no longer one disease; it is thousands of diseases. The downside is that the sample size gets really small.

Now, instead of enrolling a control group in your trial, which takes time and money, you could use data from the real world. To do that, you need high quality data and you need data with outcomes, so you can match a real-world synthetic arm.

FDA clears first cell-based gene therapy forlymphoma

How does COTA help oncology pharmaceutical manufacturers with real-world data?

COTA was founded by cancer scientists with a lot of experience in the hematology cancer space and we have access to 1.2 million oncology patient records. The data is comprehensive and diverse because of our partnerships with some of the leading cancer centers.

We use nurses and doctors who are trained for abstracting data from clinical records. We train our abstractors on specific cancers — such as breast cancer and multiple myeloma — and each of those teams goes through a really rigorous process. Once they are onboarded, they are entering data into our technology platform, which has ways of catching errors built into it.

We maintain a live dynamic feed, so we are able to continually update the medical record with the latest information. It shows you what the ultimate clinical outcome for patients are and that allows us to keep up with the latest therapies approved and monitor how they are being used in the real world.

How will COTA’s real-world data help Kite specifically?

Kite is one of the pioneers in CAR-T therapies. They are looking to COTA to make sure they are accelerating their drug development pipeline. In addition, now that they have a product market, they need to know the clinical benefit of that product in patients in the real world.

Pharma maker seeks fast approval of lymphoma treatment

Precision medicine may mean smaller clinical trials. Collecting real-world data can help supply some of the same information as a control group.


A conversation about real-world data with COTA's Viraj Narayanan

FDA cleared a new oral drug for multiple sclerosis (MS),along with an injection for adult and pediatric diabetic patients with severe glycemia.

Ponesimod (Ponvory) is a new once-daily oral medication from Janssen Pharmaceutical, owned by Johnson & Johnson, to treat adults with relapsing forms of multiple sclerosis to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Ponvory has “superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by over a decade of cumulative clinical research,” Janssen said in a 

Janssen conducted a 2-year, head-to-head Phase 3 clinical trial in which Ponvory 20 mg demonstrated superior efficacy in significantly reducing annual relapses by 30.5% compared to teriflunomide (Aubagio) 14 mg in patients with relapsing MS, according to the pharma maker.

During the study, 71% of patients treated with Ponvory had no confirmed relapses, compared to 61% in the teriflunomide group. In addition, 9 in 10 Ponvory-treated patients did not have worsening of 3-month disability, and Ponvory showed a numerical benefit in delaying disability progression.

FDA also approved dasiglucagon injection (Zegalogue, Zealand Pharma) to treat severe hypoglycemia in pediatric and adult patients with diabetes 6 years and older. Zealand expects the medication to be available in June.

FDA clears first ready-to-use insulin for IV injection

“This approval will help enable appropriate children and adults with diabetes to be able to address sudden and severe hypoglycemia, which can quickly progress from a mild event to an emergency,” said Jeremy Pettus, MD, assistant professor of medicine at the University of California, San Diego, in a 

Zegalogue provided resolution of severe hypoglycemia following administration with a median time to blood glucose recovery of 10 minutes in clinical studies, according to Pettus.

FDA’s approval was based on efficacy results from 3 randomized, double-blind, placebo-controlled multicenter Phase 3 studies of Zegalogue in children aged 6 to 17 and in adults with type 1 diabetes.

The primary endpoint was successfully achieved across the adult and pediatric studies with a significantly faster median time to blood glucose recovery of 10 minutes following Zegalogue administration compared to 30 to 45 minutes with placebo, Zealand Pharma said. In the main Phase 3 adult trial, 99% of patients recovered within 15 minutes.

The agency also gave the green light to Zegalogue, an injectable treatment for severe hypoglycemia.

FDA approves Ponvory, once-a-day oral drug for MS 

, a San Francisco biotech startup, and GlaxoSmithKline said they will submit an Emergency Use Authorization (EUA) application to FDA after positive trial results of their monoclonal antibody treatment for COVID-19.

An Independent data monitoring committee (IDMC) recommended that a Phase 3 trial evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment because of evidence of profound efficacy, the two pharmaceutical manufacturers said in a 

FDA grants emergency use for COVID-19 treatment

VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants, based on in vitro data from pseudotyped virus assays, according to the companies. “In contrast to other monoclonal antibodies, VIR-7831 binds to a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop,” they said.

“The dual-action design of VIR-7831 to both block viral entry into healthy cells and clear infected cells, as well as its high barrier to resistance, are key distinguishing characteristics,” said George Scangos, Ph.D., CEO of Vir.

“These findings, paired with our pending publication of resistance data, demonstrate the potential of VIR-7831 to prevent the most severe consequences of COVID-19 and highlight its potential ability to protect against the current circulating strains of the virus.”

 for the investigational monoclonal antibody therapy bamlanivimab (Eli Lilly and Company) to treat mild-to-moderate COVID-19 in adult and pediatric patients. The agency has since approved other monoclonal antibody treatments for SARS-CoV-2.

FDA clears Regeneron’s COVID-19 monoclonal antibody treatment and a home test

Vir Biotechnology and GlaxoSmithKline are also seeking emergency use authorizations for the treatment in other countries.

The IDMC recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo. VIR-7831 was also well tolerated, according to the pharma makers.

“As the trial remains ongoing and blinded with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed,” they said.

VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company. The trial is designed to assess the safety and efficacy of bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralising antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19.

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

A data monitoring committee stopped a trial early because of evidence of "
profound efficacy," according to a press release issued by Vir Biotechnology and GlaxoSmithKline. 

San Fran biotech, GSK seeking EUA for COVID-19 monoclonal antibody treatment

Gilead Sciences and Merck will co-develop and co-commercialize long-acting HIV treatments, 

The treatments combine Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a 2-drug regimen.

HIV therapeutics market to reach $28 billion in 2029

There is an increased demand for HIV treatments, due to some HIV antiretrovirals being used to treat COVID-19 globally. The global HIV drugs market is expected to grow nearly 6% annually to reach $34.2 billion in 2023, according to 

Across 7 major global markets, HIV sales are projected to reach $28 billion in sales in 2029, driven by injectable medications, according to 

Islatravir and lenacapavir are both potentially first-in-class medicines in late-stage clinical trials, with significant clinical data generated so far, Merck and Gilead said. “Both medicines have long half-lives and have demonstrated activity at low dosages in clinical studies, which support development as an investigational combination regimen with long-acting formulations, both oral and injectable,” they noted.

Viiv Healthcare’s Cabenuva will be available in the U.S. in February

Daily, single tablet regimens are available for those with HIV, but options that would allow for less frequent, oral dosing or infrequent injections rather than daily dosing “have the potential to address preference considerations, as well as issues associated with adherence and privacy,” they said.

“This collaboration with Gilead brings together two companies dedicated to the fight against HIV to develop potential new long-acting treatment options, and is an important step forward in our strategy to harness the full potential of islatravir for the treatment of HIV,” said Kenneth C. Frazier, chairman and CEO of Merck.

The first clinical studies of the oral combination are expected to begin in the second half of 2021.

FDA clears first-in-class HIV-1 treatment

Companies are working on a 2-drug regimen of Gilead's lenacapavir and Merck’s  islatravir.

Gilead, Merck partner up on long-acting HIV treatment

’s tivozanib (Fotivda) to treat adults with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies.

The drugmaker expects the oral, next-generation vascular endothelial growth factor tyrosine kinase inhibitor to be available by the end of March.

New Cabometyx-Opdivo combo for renal cell carcinoma treatment

“We believe in Fotivda’s potential to provide a differentiated treatment option for the growing number of individuals in the U.S. with relapsed or refractory RCC,” said Michael Bailey, president and CEO of AVEO, in a 

With advances in RCC treatment, patients are living longer, increasing the need for proven, well-tolerated treatment options in the relapsed or refractory setting,” said Brian Rini, MD, chief of clinical rials at the Vanderbilt Ingram Cancer Center and principal investigator of AVEO’s TIVO-3 trial.

AVEO’s TIVO-3 study is the first positive Phase 3 study in RCC patients who received 2 or more prior systemic therapies, and also the first Phase 3 RCC study to include a predefined population of patients who have received prior immunotherapy, the current standard of care in earlier-line treatment, according to Rini.

“With this approval, I believe Fotivda represents an attractive intervention, and expect it to play a meaningful role in the evolving RCC treatment landscape,” Rini said.

FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment

In the Phase 3 trial comparing Fotivda or sorafenib (Nexavar, other brands), median progression-free survival (PFS) was 5.6 months in the Fotivda arm versus 3.9 months in those treated with sorafenib. Median overall survival was 16.4 and 19.2 months for the Fotivda and sorafenib arms, respectively.

The objective response rate (ORR) was 18% for the Fotivda arm and 8% for the sorafenib arm.

According to an FDA press release, the most common adverse reactions were fatigue, hypertension, diarrhea, decrease appetite, nausea, dysphonia, hypothyroidism, cough and stomatitis.

Roche withdraws bladder cancer indication for blockbuster Tecentriq