FDA Updates: Keytruda Indications; Venclexta Combo; Pain Reliever Warning


FDA offers new options in classical Hodgkin lymphoma, and a warning for pregnant women about common pain relievers.

Keytruda for earlier cHL indications. Merck’s Keytruda (pembrolizumab) on Friday received expanded FDA indications that include treatment for relapsed or refractory classical Hodgkin lymphoma (cHL) in adults whose disease progresses after their first treatment. FDA also approved Keytruda for a pediatric cHL that does not respond to treatment, or cHL that has relapsed after 2 or more lines of therapy. Keytruda had previously been approved for adult and pediatric patients with refractory cHL who have relapsed after 3 or more prior lines of therapy. The therapy is also approved to treat multiple other types of cancer, including gastric, esophageal, cervical, melanoma, lung, and renal cancers.

Venclexta in combination in AML. Also on Friday, FDA approved Genentech’s Venclextra (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years of age or older. The announcement follows provisional approval that had been granted under FDA’s accelerated approval program in November 2018. Full approval is supported by results that show the combination produces extended overall survival for patients with AML who cannot tolerate intensive duction chemotherapy, Genentech’s Chief Medical Officer and Head of Global Product Development Levi Garraway, MD, PhD, said. Data from trials in support of the full approval were presented earlier this year at the American Society of Clinical Oncology and at the European Hematology Annual Congress, and recently published in the New England Journal of Medicine.

Pain medication in pregnancy. FDA warned that using a type of pain reliever and fever reducer in the second half of pregnancy could lead to complications, and required label changes for nonsteroidal anti-inflammatory drugs (NSAIDs). The changes explain that women taking these medications at 20 weeks or later in pregnancy could risk rare by serious kidney problems in their unborn baby, leading to low levels of amniotic fluid and the potential for pregnancy-related complications. NSAIDs include both prescription and over-the-counter medications such as ibuprofen, naproxen, diclofenac, and celecoxib. However, these recommendations do not apply to the use of low-dose aspirin (81 mg). FDA said low-dose aspirin should be taken under the direction of a health care professional.

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