Kristi Rosa

The FDA has approved ropeginterferon alfa-2b-njft for use as a treatment in patients with polycythemia vera.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the conditional marketing authorization of sotorasib for the treatment of adult patients with advanced non–small cell lung cancer whose tumors harbor a KRAS G12C mutation and who have progressed after at least 1 prior line of systemic therapy.

Gamida Cell Ltd. has completed a Type B Pre-Biologics License Application meeting with the FDA to discuss the investigational advanced cell therapy omidubicel as a potential therapeutic option for patients with blood cancers who require stem cell transplant.

The FDA has granted an orphan drug designation to LYT-200, a fully human IgG4 monoclonal antibody targeting galectin-9, for use as a potential therapeutic option for patients with pancreatic cancer.

The combination of nivolumab and low-dose ipilimumab resulted in a deep and durable clinical benefit when used in the first-line treatment of patients with microsatellite instability–high and mismatch repair deficient metastatic colorectal cancer.

The FDA has granted an orphan drug designation to the HER2-targeted natural killer cell engager therapy, DF1001, as a potential therapeutic option for patients with esophageal cancer.

The FDA has greenlit an investigation new drug application to expand the ongoing phase 1/2 ABILITY trial, which is evaluating the beta-only IL-2 superagonist MDNA11 in patients with solid tumors, to clinical trial sites in the United States.

The FDA granted a fast track designation to the selective AXL inhibitor bemcentinib in combination with a PD-1/PD-L1 agent in the treatment of patients with STK11-altered advanced or metastatic non–small cell lung cancer without actionable mutations.

The addition of nivolumab to chemotherapy resulted in a statistically significant and clinically meaningful improvement in event-free survival vs chemotherapy alone, when administered prior to surgery in patients with resectable stage IB to IIIA non–small cell lung cancer.

With the rise of immunotherapy, patients with lung cancer are experiencing improved outcomes that have allowed for prolonged survival, but it is important to ensure that the adverse effects associated with these novel agents are effectively managed so that their achieved efficacy does not come at the cost of quality of life.

Ripretinib did not significantly improve progression-free survival over sunitinib in patients with gastrointestinal stromal tumor who previously received imatinib, missing the primary end point of the phase 3 INTRIGUE trial.

The FDA granted a fast track designation to EZM0414, a first-in-class, oral SETD2 inhibitor, for use as a potential therapeutic option in adult patients with relapsed or refractory diffuse large B-cell lymphoma.

The European Medicines Agency granted an orphan drug designation to devimistat for the treatment of patients with relapsed or refractory Burkitt lymphoma. The novel compound targets mitochondria in tumor cells.

Leronlimab was found to improve survival in patients with CCR5-positive metastatic triple-negative breast cancer in whom at least 2 prior lines of therapy had failed, according to data from an updated analysis of a Compassionate Use Study, a phase 1b/2 study, and from a basket study.

The FDA has extended the Prescription Drug User Fee Act target date for the biologics license application seeking the approval of the CAR T-cell therapy ciltacabtagene autoleucel for use in adult patients with relapsed and/or refractory multiple myeloma.

Sesen Bio met with the FDA to discuss questions related to the Chemistry, Manufacturing, and Controls that were raised in the complete response letter previously issued by the regulatory agency regarding the biologics license application for Vicineum as a potential treatment for patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.

Adjuvant pembrolizumab continued to showcase improved relapse-free survival over placebo in patients with resected high-risk stage II melanoma with 6 months of additional follow-up.

The FDA has accepted for review a biologics license application for the use of toripalimab in combination with gemcitabine and cisplatin in the frontline treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma, and for use as a single agent in the second- or later-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma following platinum-containing chemotherapy.

The FDA has accepted a new drug application for the PI3Kδ inhibitor parsaclisib for use in the treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma.

Devimistat, which is being evaluated in combination with modified FOLFIRINOX in the frontline treatment of patients with metastatic adenocarcinoma of the pancreas, failed to meet the primary end point of overall survival in the phase 3 AVENGER 500 trial.

The FDA has granted an accelerated approval to asciminib for patients with Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase who have previously been treated with 2 or more TKIs, and for those with Ph-positive CML in chronic phase with a T315I mutation.

The clinical-stage immunotherapy company PDS Biotechnology Corporation has announced the temporary suspension of recruitment to the National Cancer Institute–led phase 2 trial, which is evaluating a novel triplet combination comprised of PDS0101 and 2 immunomodulating agents in patients with advanced human papillomavirus cancers.

The FDA has granted a priority review to tisagenlecleucel for use in adult patients with relapsed or refractory follicular lymphoma.

Treatment with the next-generation anthracycline annamycin was found to result in preliminary clinical activity without dose-limiting toxicities in patients with soft tissue sarcoma lung metastases.

The administration of NBTXR3 monotherapy activated by radiotherapy resulted in encouraging survival improvements in difficult-to-treat elderly and frail patients with locally advanced head and neck squamous cell carcinoma who are ineligible for cisplatin and intolerant to cetuximab.

The FDA has granted a fast track designation to the interleukin-2 variant immunotherapy nemvaleukin alfa for use in combination with pembrolizumab in the treatment of patients with platinum-resistant ovarian cancer.

The FDA has granted a fast track designation to the universal cancer vaccine UV1 for use in combination with checkpoint inhibitors in patients with unresectable or metastatic melanoma, either as an add-on therapy to pembrolizumab or to ipilimumab.

Although the addition of eryaspase to chemotherapy improved overall survival over chemotherapy alone in patients with metastatic pancreatic cancer, the difference in benefit was not found to be statistically significant, missing the primary end point of the phase 3 TRYbeCA-1 trial.

The combination of durvalumab and chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone when used in the first-line treatment of patients with advanced biliary tract cancer, meeting the primary end point of the phase 3 TOPAZ-1 trial.

Canakinumab plus pembrolizumab and platinum-based doublet chemotherapy did not significantly improve progression-free survival or overall survival in previously untreated patients with locally advanced or metastatic non–small cell lung cancer, missing the primary end points of the phase 3 CANOPY-1 trial.