FDA Policy/General

FDA Cites Krazati Provider Web Page

The CDER Office of Prescription Drug Promotion (OPDP) says a Web page targeting providers with information on the efficacy of Mirati Therapeutics’ Krazati (adagrasib) tablets, for oral use, as shown in the KRYSTAL-1 trial, makes false or misleading claims about the drug’s benefits. An 8/1 untitled letter says the violations are particularly concerning because the promotional communication makes misleading representations about Krazati efficacy in patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer. The letter says the FDA Bad Ad program has received multiple complaints about the Web page.

OPDP says Krazati is indicated for treating adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer as determined by an FDA-approved test, who have received at least one prior systemic therapy. The indication was approved under accelerated approval based on objective response rate and duration of response.

The letter details listings in the Web page’s Efficacy menu section covering some efficacy metrics. OPDP challenges the listings and their supporting data, saying the trial was not designed to evaluate the claimed results.

Mirati was told to respond with a list of all its Krazati promotional materials that make similar representations and a plan for either discontinuing such communications or stopping the distribution of the drug.

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