Drugs

Lilly’s Retevmo Gains Regular FDA Approval

FDA has granted regular approval to Eli Lilly for its previously accelerated-approval Retevmo (selpercatinib) for treating adult patients with locally advanced or metastatic non-small cell lung cancer with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. The agency also approved Thermo Fisher Scientific’s Oncomine Dx Target Test as the companion diagnostic for selpercatinib.

The conversion to regular approval was based on data from an additional 172 patients and 18 months of additional follow-up to assess durability of response (DOR), an FDA release says. “Among 69 treatment-naïve patients, [objective response rate] ORR was 84% (95% CI: 73, 92) with a DOR of 20.2 months (95% CI: 13, not estimable),” it says. “Among 247 patients previously treated with platinum-based chemotherapy, ORR was 61% (95% CI: 55, 67) with a DOR of 28.6 months (95% CI: 20, not estimable).”

The agency says the most common adverse reactions in patients were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache. View full prescribing information for Retevmo.

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