Drugs

Novartis Gets Full Approval for Tabrecta

FDA has granted full approval to Novartis for its previously accelerated-approved Tabrecta (capmatinib) for treating adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping (as detected by an FDA-approved test).

Accelerated approval was gained 5/2020 based on the therapy’s overall response rate (ORR) and duration of response (DOR) in the GEOMETRY mono-1 trial (NCT02414139). “The conversion to regular approval was based on data from an additional 63 patients, as well as an additional 22 months of follow- up time to assess durability of response and verify clinical benefit,” an FDA release says. In 60 treatment-naïve patients, ORR was 68% and DOR was 16.6 months. Among 100 previously treated patients, ORR was 44% and DOR was 9.7 months.

The most common adverse reactions seen in more than 20% of patients were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite, the agency says.

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