Drugs

Celcuity Files sNDA for Revtorpyk Expanded Use

Celcuity has submitted a supplemental NDA for Revtorpyk (gedatolisib) for treating patients with hormone receptor positive, human epidermal growth factor receptor 2 negative (HER2-), locally advanced or metastatic breast cancer (ABC) with a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy. Last month, the drug was approved for use in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, HER2-negative locally ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

“This submission allows us to potentially make Revtorpyk available to all patients with HR+/HER2- locally advanced or metastatic breast cancer, regardless of PIK3CA mutation status,” the company says in a statement.

The submission is based on data from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial. In the trial, the drug plus fulvestrant and palbociclib (Revtorpyk-triplet) reduced the risk of disease progression or death by 50% versus alpelisib plus fulvestrant. Median progression-free survival (PFS) was 11.1 months with the Revtorpyk-triplet versus 5.6 months with alpelisib plus fulvestrant. Additionally, Revtorpyk plus fulvestrant reduced the risk of disease progression or death by 49% versus alpelisib plus fulvestrant, and median PFS was 11.3 months with Revtorpyk plus fulvestrant versus 5.6 months with alpelisib plus fulvestrant.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome