An advisory committee recommends against approving an anemia drug. Darzalex Faspro receives another indication, Bayer receives approval for Kerendia for chronic kidney disease, and FDA delays its decision on sNDAs for JAK inhibitor therapies for atopic dermatitis.
Merck has submitted the data from the study KEYNOTE-522 to the FDA for review.
After generic entry, Zytiga’s market share fell to about 14% and monthly net sales across the entire market fell 85%.
A permanent code is expected in the third quarter of 2021.
The new indication provides a subcutaneous option for multiple myeloma that can be administrated in minutes, rather than hours.
Keytruda loses one indication but gains another, Biogen narrows use of Aduhelm, Padcev gets regular approval and expanded indication, Amgen submits application for asthma biologic, agency issues complete response letter for diabetes prevention therapy teplizumab, Novartis resubmits NDA for inclisiran.
MHE Associate Editor, Briana Contreras, spoke with CEO of Inteliquet, a cancer solutions provider that strives to match patients to clinical trials accurately and promptly in healthcare, Marie Lamont. In this episode Marie discusses the challenges that have affected clinical trials and cancer screenings and how to get trials back on track through technology to avoid the wave of undiagnosed patients post-COVID. She also shared how broadening them through diversity can improve trials.
This approval comes days after Merck announced it would withdraw indication for third-line gastric cancer.
Merck will withdraw Keytruda's advanced gastric indication after an FDA panel vote, a drug with supply problems gets a new indication, NDAs for an HIV therapy, and other news.
The therapy, a recombinant version, was developed to address supply and manufacturing issues.
Results suggest potential for better use of precision medicine approaches.
But there is no benefit for patients receiving chemotherapy.
Kite plans to submit a supplemental BLA based on these findings.
The anticancer therapy is now available in 21-count bottles to help accommodate dispensing.
A new indication, a nonprescription switch, a recall, and new guidances round out this week’s FDA news.
The therapy is a modified poliovirus vaccine that not only kills cancer cells but also can trigger long-term immune memory.
Chances of left ventricular ejection fraction almost disappeared when patient took the ACE-inhibitor lisinopril during treatment with trastuzumab/anthracycline, according to research presented at ASCO.
Immune-related AEs can occur one to two years after treatment, are more common in combination treatments, and can be difficult to manage.
A large proportion of patients with muscle-invasive bladder cancer responded to transurethral resection of bladder tumor and a drug cocktail that included gemcitabine, cisplatin and Opdivo (nivolumab).
Phase 1b results show manageable toxicities with Venclexta and Rydapt.
The Association of Community Cancer Centers launched the ACCC Community Oncology Research Institute, which builds on the organization's mission to close the gap in cancer research through optimal community oncology partnerships.
About 2% to 3% of patients with nonsmall cell lung cancer have EGFR exon 20 insertion mutations targeted by newly approved Rybrevant.
A small fraction of those who were eligible under previous U.S. Preventive Services Task Force recommendations were screened with low-dose CT scans. New recommendations will make an additional 6.4 million Americans eligible, but a number of barriers to screening remain.
Opdivo is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.
