Drugs

FDA Unsure of ‘Unprecedented’ Jemperli Trial Plans

FDA is convening its Oncologic Drugs Advisory Committee (ODAC) 2/9 to consider GlaxoSmithKline’s proposals for two single-arm clinical trials of its Jemperli (dostarlimab), hoping to file a BLA and seek accelerated approval of a new rectal cancer indication. In advance of the meeting, FDA released a briefing document asking for ODAC input on the company’s “unprecedented use of clinical complete response rate as the major endpoint to support an approval in oncology, the trial designs that serve as the basis of a future application, and the limitations of data to inform the implementation of the proposed non-operative management strategy.”

FDA says the major ODAC discussion topics are the:

adequacy and appropriateness of proposed single-arm trials to evaluate the efficacy and safety of Jemperli, including the long-term benefits and risks of treatment in the indicated population (patients with locally advanced, treatment-naïve, mismatch-repair deficient or microsatellite-instability-high rectal cancer);
adequacy of the proposed clinical endpoints (clinical complete response rate, event-free survival) to characterize and verify the benefit of Jemperli, including the proposed timing of the endpoint analyses;
appropriateness of the study population for a non-operative treatment approach;
role of data from a study evaluating Jemperli for the treatment of locally advanced colon cancer; and
potential impact of the variability in care, expertise, etc., across multi-disciplinary study staff and study sites on study conduct and, ultimately, on clinical outcomes.

Jemperli was first approved in 2021 for a specific subset of recurrent or advanced endometrial cancer patients who have deficient mismatch repair (dMMR). The indication was later expanded to include all adults with dMMR recurrent or advanced solid tumors who have progressed or stagnated on earlier therapy.

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