Jason M. Broderick

The FDA has approved the combination of nivolumab and ipilimumab for the first-line treatment of patients with PD-L1–positive metastatic or recurrent non–small cell lung cancer that does not have EGFR or ALK genomic tumor aberrations.

The FDA has approved rucaparib for the treatment of adult patients with BRCA-mutant recurrent, metastatic castration-resistant prostate cancer.

The FDA has approved pomalidomide for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy, or in patients with Kaposi sarcoma who are HIV-negative.

The FDA issued a complete response letter stating it will not approve an application for avapritinib for the fourth-line treatment of patients with gastrointestinal stromal tumor. 

Ivosidenib induced a 63% reduction in the risk of disease progression or death versus placebo in previously treated patients with IDH1-mutant advanced cholangiocarcinoma, according to findings from the phase 3 ClarIDHy study published in the Lancet Oncology.

Ivosidenib induced a 63% reduction in the risk of disease progression or death versus placebo in previously treated patients with IDH1-mutant advanced cholangiocarcinoma, according to findings from the phase 3 ClarIDHy study published in the Lancet Oncology.

The European Commission has approved brentuximab vedotin for use in combination with chemotherapy for the frontline treatment of adult patients with systemic anaplastic large cell lymphoma.

The FDA has issued a Refusal to File letter to Bristol Myers Squibb and bluebird bio, Inc., regarding their Biologics License Application (BLA) for the BCMA-directed CAR T-cell therapy decabtagene vicleucel.

The FDA has requested additional details before accepting a biologics license application for idecabtagene vicleucel for the treatment of patients with multiple myeloma.

Tucatinib has been approved in Switzerland for use in combination with trastuzumab and capecitabine for patients with previously treated metastatic HER2-positive breast cancer.

Omidubicel met the primary end point of time to neutrophil engraftment in patients with high-risk hematologic malignancies undergoing a bone marrow transplant.

Tucatinib has been approved in Switzerland for use in combination with trastuzumab and capecitabine for patients with previously treated metastatic HER2-positive breast cancer.

Adding isatuximab to carfilzomib and dexamethasone improved progression-free survival in patients with relapsed multiple myeloma, meeting the primary end point of the phase 3 IKEMA trial.

The FDA has approved myChoice CDx for use as a companion diagnostic to identify patients with advanced ovarian cancer with positive homologous recombination deficiency status, making them eligible to receive frontline maintenance treatment with olaparib plus bevacizumab.

The FDA has approved myChoice CDx for use as a companion diagnostic to identify patients with advanced ovarian cancer with positive homologous recombination deficiency status, making them eligible to receive frontline maintenance treatment with olaparib plus bevacizumab.

The FDA has granted a breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

The FDA has granted a breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

The FDA has approved selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion–positive non–small cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion–positive thyroid cancer.

The anti­–folate receptor alpha antibody-drug conjugate STRO-002 showed early clinical promise in patients with advanced ovarian cancer.

The FDA has approved olaparib plus bevacizumab for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab.

The vaccine BVAC-C demonstrated durable antitumor activity in patients recurrent cervical cancer.

Trastuzumab emtansine has been approved in the UK for the adjuvant treatment of patients with HER2-positive early breast cancer.

A supplemental New Drug Application has been submitted to the Japanese Ministry of Health, Labour and Welfare seeking approval of trastuzumab deruxtecan for the treatment of patients with HER2-positive metastatic gastric cancer

Adding the PD-1 inhibitor sintilimab injection to gemcitabine and platinum-based chemotherapy improved progression-free survival as a frontline treatment in squamous non–small cell lung cancer.

The FDA has approved capmatinib for the treatment of patients with non–small cell lung cancer.

The FDA has granted an orphan drug designation to MIV-818 for the treatment of patients with hepatocellular carcinoma.

The FDA has extended the review period for a biologics license application for lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma.

VERU-111 demonstrated antitumor activity and durable PSA declines in men with metastatic castration-resistant prostate cancer who are resistant to at least 1 novel androgen-blocking agent.

A doublet combining umbralisib and ublituximab improved progression-free survival in patients with chronic lymphocytic leukemia.

Cemiplimab induced clinically meaningful and durable responses in patients with advanced basal cell carcinoma.