Jason M. Broderick

Idecabtagene vicleucel induced a response in nearly three-fourths of patients with heavily pretreated relapsed/refractory multiple myeloma, according to topline findings from the pivotal phase 2 KarMMA trial.

The FDA has approved atezolizumab plus bevacizumab for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

Over half of patients with PIK3CA-positive, HR-positive/HER2-negative advanced breast cancer who had prior treatment with a CDK4/6 inhibitor plus an aromatase inhibitor were alive without disease progression 6 months after starting treatment with alpelisib plus fulvestrant.

Adding avelumab to best supportive care improved the median overall survival by over 7 months in patients with locally advanced or metastatic urothelial carcinoma, according to findings from the phase 3 JAVELIN Bladder 100 study.

Maintenance niraparib improved progression-free survival in Chinese patients with recurrent ovarian cancer who were in a complete or partial response to platinum-based chemotherapy, meeting the primary end point of the phase 3 NORA study.

The National Comprehensive Cancer Network has updated its Prostate Cancer guidelines to include the PARP inhibitor rucaparib.

The FDA has granted Fast Track designation to onvansertib for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer.

The FDA’s Oncologic Drugs Advisory Committee will no longer be meeting to review a Biologics License Application for margetuximab for the treatment of patients with HER2-positive breast cancer.

Atezolizumab in combination with carboplatin and etoposide has been approved in the UK for the frontline treatment of patients with extensive-stage small cell lung cancer.

The FDA has approved nivolumab combined with ipilimumab and chemotherapy for use as a frontline treatment for patients with metastatic or recurrent non–small cell lung cancer.

Adding ipatasertib to paclitaxel continued to demonstrate a clinically meaningful extension in overall survival in patients with triple-negative breast cancer.

Belumosudil (KD025) continued to show high levels of clinical activity in patients with previously treated chronic graft-versus-host disease.

A supplemental New Drug Application has been submitted to the FDA for the use of selinexor as a treatment for patients with multiple myeloma following at least 1 line of prior therapy.

The FDA has approved two companion diagnostics to identify patients with metastatic castration-resistant prostate cancer with homologous recombination repair mutations, making them eligible for treatment with olaparib.

A supplemental New Drug Application has been submitted to the FDA for the use of selinexor as a treatment for patients with multiple myeloma following at least 1 line of prior therapy.

The FDA has approved olaparib for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene–mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone acetate.

Pembrolizumab combined with trastuzumab and chemotherapy demonstrated promising clinical activity in patients with HER2-positive metastatic esophagogastric cancer.

The FDA has approved PD-L1 IHC 28-8 pharmDx for use as a companion diagnostic to identify patients with metastatic non–small cell lung cancer with PD-L1 tumor expression ≥1%, making them eligible for frontline treatment with nivolumab plus ipilimumab.

The FDA has granted a breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki for the treatment of patients with HER2-positive metastatic non–small cell lung cancer.

The FDA has granted a breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki for the treatment of patients with HER2-positive metastatic non–small cell lung cancer.

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

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.