FDA News

The FDA has had a busy couple of weeks, approving new agents to treat a variety of cancers.

The FDA has approved selinexor as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma, not otherwise specified, who have received ≥2 prior therapies.

The FDA approved tazemetostat to treat relapsed/refractory follicular lymphoma in 2 different indications.

The FDA has approved pembrolizumab (Keytruda) to treat adult and pediatric patients with unresectable or metastatic solid tumors that are tissue tumor mutational burden–high (≥10 mutations/megabase) and have progressed following prior therapy and who have no satisfactory alternative treatment options.

The FDA expanded the approval of gemtuzumab ozogamicin (Mylotarg) to include newly diagnosed pediatric patients (1 month or older) with CD33-positive acute myeloid leukemia (AML).

The FDA approved lurbinectedin (Zepzelca) for the treatment of adult patients with metastatic small cell lung cancer with disease progression, following platinum-based chemotherapy.

On Friday, the FDA expanded the approval for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) types 16,18,31, 33, 45, 52, and 58, according to Merck, the manufacturer of the vaccine.

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.

The FDA has granted an orphan drug designation to fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of patients with gastric cancer, including gastroesophageal junction (GEJ) cancer.

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.