Drugs

Panel to Review Continued Approval of 6 Drug Indications

FDA has announced a three-day (4/27-29) Oncologic Drugs Advisory Committee meeting to discuss the continued approval of six indications associated with three monoclonal antibodies that gained accelerated approval but failed to show clinical benefit in subsequent confirmatory trials. The panel meeting and FDA’s review is part of an industry-wide evaluation of accelerated approvals in oncology in which confirmatory trials failed to demonstrate effectiveness, the agency says. Already, over the past three months, Genentech (Tecentriq), Merck (Keytruda), AstraZeneca (Imfinzi) and Bristol Myer Squibb (Opdivo), have announced indication withdrawals (see story) as part of FDA’s ongoing evaluation. The products and indications under the panel review are:

Atezolizumab: in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1; for treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy (Genentech Inc.).
Pembrolizumab: for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy; the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy; the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Merck Sharpe & Dohme Corp.).
Nivolumab: as a single agent for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Bristol Myers Squibb).

As of 12/31/2020, 253 products have been granted accelerated approval, and, to date, only 6% of these have been withdrawn, FDA says. Based on the updates provided at panel meeting, committee members will have a general discussion on the drugs’s continued approval of the specific indications and if additional trials will be required.

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