Drugs

FDA Grants Traditional Approval to Gavreto

FDA has granted traditional approval for Genentech’s Gavreto (pralsetinib) for treating adult patients with metastatic RET (rearranged during transfection) fusion-positive non-small cell lung cancer (NSCLC) as confirmed by an FDA-approved test. Pralsetinib had previously been granted accelerated approval 9/2020 for the NSCLC indication based on its initial overall response rate (ORR) and duration of response (DOR) in 114 patients enrolled in the ARROW trial. “The conversion to regular approval was based on data from an additional 123 patients and 25 months of additional follow-up to assess durability of response,” an agency release says.

The primary efficacy measures were ORR and DOR as determined by a Blinded Independent Review Committee, FDA says. “Among 107 treatment-naïve patients, ORR was 78% (95% CI: 68, 85) with a median DOR of 13.4 months (95% CI: 9.4, 23.1),” it says. “Among 130 patients previously treated with platinum-based chemotherapy, ORR was 63% (95% CI: 54, 71) with a median DOR of 38.8 months.”

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

Read more

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