Jason M. Broderick

An update on the phase 3 OCEAN study of melflufen in relapsed/refractory multiple myeloma reported that patients stayed on treatment longer than had been previously estimated.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended olaparib for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic adenocarcinoma.

The phase 3 PALLAS trial exploring palbociclib (Ibrance) in patients with HR-positive, HER2-negative early breast cancer is unlikely to demonstrate a statistically significant improvement in the study’s primary end point of invasive disease-free survival.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended entrectinib for the treatment of adult and pediatric patients ≥12 years of age with solid tumors that harbor an NTRK fusion, as well as for the treatment of adult patients with ROS1-positive, advanced non–small cell lung cancer not previously treated with ROS1 inhibitors.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the PI3K inhibitor alpelisib for use in combination with fulvestrant as treatment for patients with breast cancer.

The combination of cabozantinib and atezolizumab showed clinically meaningful activity in patients with metastatic castration-resistant prostate cancer.

Combining the anti–PD-1 agent tislelizumab with chemotherapy improved progression-free survival compared with chemotherapy alone as a frontline treatment in Chinese patients with advanced squamous non–small cell lung cancer.

The latest results from the phase 3 BEACON CRC study continued to show an overall survival benefit for encorafenib plus cetuximab with or without binimetinib compared with cetuximab plus irinotecan-containing regimens in patients with BRAF V600E–mutated metastatic colorectal cancer.

The FDA has approved the combination of ramucirumab and erlotinib as a frontline treatment for patients with metastatic non–small cell lung cancer whose tumors harbor EGFR mutations.

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.