FDA News

The FDA has granted margetuximab an Orphan Drug designation for the treatment of patients with gastric and gastroesophageal junction (GEJ) cancer, according to MacroGenics, Inc., the manufacturer of the Fc-engineered monoclonal antibody.

The FDA has accepted a Biologics License Application (BLA) for ropeginterferon alfa-2b (P1101) for use as a treatment for patients with polycythemia vera (PV) in the absence of symptomatic splenomegaly, according to PharmaEssentia Corporation, the manufacturer of the novel pegylated interferon.

The FDA has approved the combination of ramucirumab (Cyramza) and erlotinib (Tarceva) as a frontline treatment for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.

The FDA has approved the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

The FDA has given a fast track designation to onvansertib for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer.

The FDA has granted a Fast Track designation to CLR 131 for use as a treatment for patients with lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM) who have received at least 2 prior treatment regimens.

The FDA has approved brigatinib (Alunbrig) for the first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC), as detected by an FDA-approved test.

Karyopharm Therapeutics Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for the use of selinexor (Xpovio) as a treatment for patients with multiple myeloma following at least 1 line of prior therapy.

The FDA continues to approve new cancer drugs, with multiple treatment regimens getting the agency’s OK within the last week.

The FDA has approved the single-agent atezolizumab as a first-line treatment for patients with metastatic non-small cell lung cancer who have a high PD-L1 expression and no EGFR or ALK genomic tumor aberrations.

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 granted priority review to a new drug application for CC-486 for the maintenance treatment of adult patients with acute myeloid leukemia based on efficacy and safety results from the pivotal phase III QUAZAR AML-001 study.

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.