Kristi Rosa

The FDA has approved sirolimus albumin-bound particles for injectable suspension for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor.

The addition of sintilimab to a bevacizumab biosimilar and pemetrexed/cisplatin resulted in a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with EGFR-mutated, nonsquamous non–small cell lung cancer who progressed after an EGFR TKI.

The European Commission has granted a conditional marketing authorization to pralsetinib for use as a single agent in adult patient with RET fusion–positive advanced non–small cell lung cancer who did not previously receive a RET inhibitor.

The addition of quizartinib to chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival vs standard chemotherapy alone in patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.

The FDA has approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Sacituzumab govitecan-hziy significantly improved overall response rate in Chinese patients with metastatic triple-negative breast cancer.

The combination of the PD-1/VEGF bispecific antibody AK112 and the PARP inhibitor olaparib is under investigation as a potential treatment option for patients with BRCA1/2 germline wild-type, platinum-sensitive, recurrent ovarian cancer as part of a phase 1b/2 trial.

The investigative agent SL-172154 was found to be well tolerated, with no dose-limiting toxicities observed, in patients with platinum-resistant ovarian cancer, according to findings from a phase 1 dose-escalation trial presented during the 2021 SITC Annual Meeting.

The FDA granted an orphan drug designation to toripalimab for the treatment of patients with esophageal cancer.

Tidutamab was found to be well tolerated with a best overall response of stable disease in patients with advanced, well-differentiated neuroendocrine tumors of pancreatic, gastrointestinal, lung and undetermined origin.

ICT01, a humanized anti-BTN3A monoclonal antibody that selectively activates γ9δ2 T cells, has demonstrated early signs of biological activity when given as a single agent or in combination with pembrolizumab in patients with advanced solid tumors.

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.