Kristi Rosa

The anti-TIGIT immunotherapy tiragolumab in combination with atezolizumab did not improve progression-free survival over atezolizumab alone in the first-line treatment of patients with PD-L1–high locally advanced or metastatic non–small cell lung cancer.

The addition of adjuvant abemaciclib to endocrine therapy resulted in a clinically meaningful reduction in the risk of developing invasive disease, particularly incurable distant metastatic disease, in patients with high-risk, hormone receptor–positive, HER2-negative, early breast cancer who comprised cohort 1 of the phase 3 monarchE trial.

A novel combination comprised of the investigational bispecific antibody CTX-009 and paclitaxel was found to produce responses in 4 subtypes of biliary tract cancer with favorable safety and tolerability, according to interim results from an ongoing phase 2 trial.

The FDA has approved fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received an anti–HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within 6 months of therapy completion.

The FDA has granted a fast track designation to the myeloid kinome inhibitor, HM43239, for use as a potential therapeutic option in patients with relapsed or refractory acute myeloid leukemia whose tumors harbor a FLT3 mutation.

The FDA has accepted a supplemental biologics license application and granted priority review to durvalumab in combination with standard gemcitabine and cisplatin for the treatment of patients with locally advanced or metastatic biliary tract cancer.

The European Commission has approved the use of cabozantinib for use as a single agent in adult patients with locally advanced or metastatic differentiated thyroid carcinoma who are refractory or not eligible to receive radioactive iodine and who have progressed during or following previous systemic treatment.

The FDA has accepted a supplemental new drug application and granted priority review to darolutamide plus docetaxel in patients with metastatic hormone-sensitive prostate cancer.

The FDA is seeking the approval of toripalimab plus gemcitabine and cisplatin in the frontline treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for use as a monotherapy in the second-line and later treatment of those with recurrent or metastatic disease.

The FDA has issued a complete response letter to the new drug application seeking the approval of surufatinib for the treatment of patients with pancreatic and extra-pancreatic neuroendocrine tumors.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval under conditional marketing authorization for mosunetuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 therapies.

The FDA has accepted for priority review a biologics license application seeking the approval of a single priming dose of tremelimumab added to regular interval durvalumab in the treatment of patients with unresectable hepatocellular carcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization to capmatinib for use as a single agent in select adult patients with advanced non–small cell lung cancer harboring a METex14 skipping alteration.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of adjuvant atezolizumab, after complete resection and platinum-based chemotherapy, in adult patients with non–small cell lung cancer with a high risk of recurrence and whose tumors express PD-L1 of 50% or higher and do not harbor EGFR mutations or ALK alterations.

The safety, tolerability, and preliminary efficacy of the irreversible, small molecule pan-FGFR inhibitor KIN-3248 is under investigation in adult patients with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations, as part of the phase 1 KN-4802 trial.

The combination of tislelizumab and gemcitabine/cisplatin continued to demonstrate a greater progression-free survival benefit than chemotherapy alone when used in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer.

The China National Medical Products Administration has approved tislelizumab for use in patients with locally advanced or metastatic esophageal squamous cell carcinoma who have disease progression or who are intolerant to frontline standard chemotherapy.

The FDA has approved the third biosimilar for bevacizumab: bevacizumab-maly (Alymsys).

The overall response rate achieved with ruxolitinib at day 28 proved to be higher than what was achieved with best available therapy in patients with steroid-refractory acute graft-vs-host disease, irrespective of organ involvement.

The pending biologics license application and supplemental new drug application seeking the approval of the combination of ublituximab and umbralisib in adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma has been voluntarily withdrawn by TG Therapeutics, Inc.

Nektar Therapeutics and Bristol Myers Squibb have announced the decision to end the global clinical development program for the combination of bempegaldesleukin and nivolumab based on findings from preplanned analyses of 2 late-stage clinical trials.

Epcoritamab was found to produce an encouraging overall response rate in patients with relapsed or refractory large B-cell lymphoma who previously received CAR T-cell therapy.

The European Commission has approved enfortumab vedotin for use as a single agent in adult patients with locally advanced or metastatic urothelial cancer who have received prior platinum-containing therapy and a PD-1/L1 inhibitor.

The FDA has cleared an investigational new drug application for 177Lu-rhPSMA-10.1 as a potential therapeutic option for patients with metastatic castration-resistant prostate cancer.

The FDA has placed a partial clinical hold on the open-label, dose-escalating phase 1/2 TakeAim Lymphoma study investigating the safety and efficacy of emavusertib in patients with relapsed or refractory B-cell malignancies.

The FDA has lifted a partial clinical hold that had been placed on studies examining magrolimab in combination with azacitidine following a review of comprehensive safety data collected from each trial.

Zanubrutinib demonstrated superiority over ibrutinib in terms of overall response rate per independent review committee assessment in adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The dual immunotherapy combination of nivolumab and ipilimumab elicited encouraging and durable responses with acceptable safety in patients with advanced or metastatic tumor mutational burden–high solid tumors that were refractory to standard therapies, meeting the primary end points of the phase 2 CheckMate-848 trial.

Zanubrutinib monotherapy continues to demonstrate durable responses with an acceptable toxicity profile in patients with relapsed or refractory mantle cell lymphoma.

The China National Medical Products Administration’s Center for Drug Evaluation has granted a breakthrough therapy designation to relmacabtagene autoleucel for use in the treatment of patients with mantle cell lymphoma.