FDA News

The FDA has approved ripretinib (Qinlock) for the fourth-line treatment of patients with advanced gastrointestinal stromal tumor (GIST).

The FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) for the frontline treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK aberrations.

The FDA approved single-agent rucaparib (Rubraca) for the treatment of patients with BRCA1/2-mutant, recurrent, metastatic castrate-resistant prostate cancer.

The FDA approved pomalidomide (Pomalyst) for the treatment of AIDS-related Kaposi sarcoma, that has become resistant to highly active antiretroviral therapy or for patients with Kaposi sarcoma who are HIV-negative.

The FDA approved selpercatinib for the treatment of non-small cell lung cancer, medullary thyroid cancer, and other thyroid cancers with RET alterations.

The FDA has approved the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer.

The FDA granted an accelerated approval to capmatinib for the treatment of adults with metastatic non-small cell lung cancer with a mutation that leads to MET exon 14 skipping (METex14).

The FDA has added 3 months to the review period for a biologics license application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after at least 2 prior therapies. The extension will allow the agency to review additional data provided by Bristol Myers Squibb, the manufacturer of the anti-CD19 CAR T-cell therapy.

The FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of adults with newly diagnosed relapsed/refractory multiple myeloma.

The FDA approved niraparib for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to frontline platinum-based chemotherapy.

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 Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) for the treatment of previously treated patients with advanced hepatocellular carcinoma.

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 has granted a priority review designation to a supplemental new drug application (sNDA) for selinexor (Xpovio) as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, who have received ≥2 prior therapies.

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 FDA has granted a priority review for the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer.

The FDA has granted a priority review to the combination treatment of nivolumab and ipilimumab to treat patients with advanced HCC.

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 granted accelerated approval to the combination of lenvatinib and pembrolizumab in the treatment of patients with advanced endometrial carcinoma.

The FDA approved entrectinib for pediatric and adult patients with certain subtypes of solid tumors, including non-small cell lung cancer.