Christine Blank

FDA expanded the approved indication for baloxavir marboxil (Xofluza, Genentech) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu.

In addition, the drug, previously available only in tablet form, is now available as granules for mixing in water, FDA said in a 

Gottlieb optimistic about COVID-19 end after positive Moderna vaccine results

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Americans will have to be more vigilant than ever as these viruses spread concurrently.”

 in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

Pfizer: COVID-19 vaccine likely ready late November

Xofluza’s safety and efficacy for post-flu exposure prevention is supported by one randomized, double-blind, controlled trial.

The trial included around 600 subjects who were exposed to a person with influenza in their household. The trial’s primary endpoint was the proportion of subjects who were infected with influenza virus and presented with fever and at least one respiratory symptom from day 1 to day 10. Of those who received Xofluza, 1% of subjects met these criteria compared with 13% of those in the placebo group.

FDA approves game-changing influenza drug

Articles

FDA official says the approval is important because of the combination of the flu season and the COVID-19 pandemic.

Xofluza, flu drug, snags new indication

FDA has cleared the monoclonal antibody treatment for COVID-19 that President Donald Trump was treated with in October. The agency also gave the go-ahead late last week to the first home self-test for the pandemic disease.

The agency issued an emergency use authorization (EUA) for casirivimab and imdevimab (Regeneron) to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kg.) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

FDA grants emergency use for COVID-19 treatment

Earlier this month, FDA issued an EUA for the another monoclonal antibody therapy, bamlanivimab (Eli Lilly and Company), to treat mild-to-moderate COVID-19 in adult and pediatric patients.

“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our healthcare system,” said FDA Commissioner Stephen M. Hahn, M.D., in a 

. “As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments.

In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together via IV infusion, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared with placebo.

However, FDA said that the combination therapy is not authorized for patients who are hospitalized with COVID-19 who require oxygen therapy because of the disease; in fact, the agency said the treatment might worsen the condition of such patients.

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

“A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation,” FDA said.

FDA also granted an EUA for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit (Lucira Health) is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, the agency said in a 

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” Hahn said.

The Lucira COVID-19 All-In-One Test Kit test, available by prescription only, is authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their healthcare provider.

It is also authorized for use in point-of-care (POC) settings such as doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages. However, samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old.

Regeneron's investigational treatment was administered to President Donald Trump in October when he was treated for COVID-19.

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

The COVID-19 pandemic could “effectively” be ended in 2021, said Scott Gottlieb, MD, former FDA commissioner, after Moderna announced very positive results from its vaccine trial.

 that its Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has an efficacy of 94.5%. Its COVE study enrolled more than 30,000 participants in the U.S.

Pfizer and BioNTech’s first interim analysis also found that their vaccine candidate, BNT162b2, 

 against COVID-19 in participants without prior evidence of SARS-CoV-2 infection.

Pfizer COVID-19 vaccine results positive, but questions remain

Pfizer expects the FDA to grant emergency approval for the vaccine later this month.

"If these full data sets hold, when the full data comes out, we may have two highly effective vaccines against Covid," Gottlieb, a board member of Pfizer, said on CNBC’s “Squawk Box."​ 

"Once we get these vaccines in sufficient qualities heading in 2021, the combination of the fact that a lot of the population will have already had COVID, combined with the fact that we'll be vaccinating the public with a highly effective vaccine, we could effectively end this pandemic in 2021 with our technology," Gottlieb said.

Michael Breen, Ph.D., director of infectious diseases and ophthalmology at GlobalData, praised the efficacy date for both Moderna and Pfizer’s vaccine candidates.

“While the efficacy of Moderna’s offering is slightly higher than that reported for Pfizer/BioNTech’s candidate, the more pressing point is the fact that these vaccines achieved this outcome at all. One candidate seeing significantly more impressive results than the FDA’s usual bar was great news, but two is unprecedented,” Breen said in a press release.

One key difference between the vaccines is that Moderna’s vaccine does not require deep-freeze storage, while Pfizer’s does, Breen said. “This creates significant logistical difficulties that could easily give the advantage for COVID-19 vaccines to Moderna.”

“More data are needed for both vaccines that might highlight differences between them and inform how each should be used. It is entirely possible that both vaccines have similar efficacies across all groups, in which case they should both be rolled out as rapidly as possible,” Breen added.

FDA approved a new indication for Merck’s blockbuster cancer drug, pembrolizumab (Keytruda), in combination with chemotherapy, to treat locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC).

Sales of Keytruda, approved to treat several different types of cancer including non-small-cell lung cancer, soared 21%, to $3.7 billion, in the third quarter of 2020.

Merck’s Keytruda snags another cancer indication

“Today’s approval is a significant milestone, as it represents the first approval for Keytruda in the breast cancer setting,” said Roy Baynes, M.D., senior vice president and head of global clinical development, chief medical officer of Merck Research Laboratories, in a 

In the phase 3 trial supporting the approval, Keytruda in combination with paclitaxel, nab-paclitaxel or gemcitabine and carboplatin, significantly improved progression-free survival for patients with advanced triple-negative breast cancer whose tumors express PD-L1 with combined positive score (CPS) greater than or equal to 10 compared with the same chemotherapy regimens alone, Baynes added.

Keytruda, in combination with the chemotherapy agents, reduced the risk of disease progression or death by 35% for patients whose tumors express PD-L1 versus the same chemotherapy regimens alone

FDA okays novel breast, colorectal cancer treatments

The multicenter, double-blind, randomized, placebo-controlled trial included 847 patients with locally recurrent unresectable or metastatic TNBC, regardless of tumor PD-L1 expression, who had not been previously treated with chemotherapy in the metastatic setting.

FDA granted accelerated approval for the indication based on progression-free survival (PFS), so continued approval for that indication may be contingent upon verification and description of clinical benefit in the confirmatory trials, Merck said.

“Approximately 15 to 20% of patients with breast cancer are diagnosed with triple-negative breast cancer, which is a difficult-to-treat and aggressive cancer,” said Dr. Hope Rugo, director of Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center. “The approval of Keytruda in combination with chemotherapy gives physicians an important new option for appropriate patients.”

Merck earned a new indication for pembrolizumab (Keytruda), in combination with chemotherapy, to treat locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC).


Christine Blank

Articles

Xofluza, flu drug, snags new indication

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

Gottlieb optimistic about COVID-19 end after positive Moderna vaccine results

Blockbuster Keytruda earns new breast cancer indication