Drugs

FDA OKs Opdivo for Previously Untreated Hodgkin Lymphoma

FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) for use with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). The FDA also granted traditional approval to nivolumab for the following indications in adults with relapsed or refractory cHL:

after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin
after three or more lines of systemic therapy that includes autologous HSCT.

Nivolumab received accelerated approval for these indications in 2016 and 2017, respectively.

Approval was based on data of nivolumab in combination with AVD that was evaluated in Study CA209-8UT, according to FDA, adding that the primary efficacy outcome measure was progression-free survival (PFS). “The study demonstrated superiority of PFS in the nivolumab plus AVD arm,” it says. “After a median follow-up of 36.7 months, there were 1.8% deaths in the nivolumab plus AVD arm and 3.4% in the brentuximab vedotin plus AVD arm.”

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