FDA News

The FDA has granted an accelerated approval to an updated dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg across all indications in adult patients.

The FDA has granted a breakthrough therapy designation to mobocertinib for the treatment of patients with EGFR exon 20–mutant non–small cell lung cancer.

The FDA approved ibrutinib (Imbruvica) plus rituximab (Rituxan) as a frontline therapy for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).

The FDA has accepted a supplemental New Drug Application (sNDA) for niraparib (Zejula) for use as a frontline maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.

The FDA granted a priority review to a supplemental biologics license application for frontline atezolizumab in patients with advanced non-squamous non-small cell lung cancer.

The FDA granted a priority review for the biologics license application for lisocabtagene maraleucel (liso-cel), to treat adults with relapsed or refractory large B-cell lymphoma.

The biologic license application is supported by data from the phase II ZUMA-2 trial, which is currently assessing the CAR T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

The agency granted full approval to pemetrexed for injection (Pemfexy), a liquid injection and branded alternative to Alimta, for nonsquamous NSCLC.

The FDA has extended the Prescription Drug User Fee Act deadline for a new drug application (NDA) for avapritinib (Ayvakit) as a treatment for adult patients with fourth-line gastrointestinal stromal tumor (GIST). The deadline, which was initially February 14, 2020, has been extended by 3 months to May 14, 2020, according to BluePrint Medicines, the developer of avapritinib.

The therapy is now approved for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

The FDA has approved the biosimilar pegfilgrastim for treatment to decrease the incidence of infection exhibited from febrile neutropenia.

The FDA has expanded the approval of aprepitant to include in its label the use of a single dose regimen in patients receiving moderately epigenetic chemotherapy.

The FDA has issued a letter about a possible risk of increased mortality among patients with a type of arterial disease who have paclitaxel-coated implants.

The FDA has approved a new agent for the treatment of severe hepatic veno-occlusive disease, a rare but often fatal complication in patients who receive chemotherapy and hematopoietic stem cell transplantation.