Global

The China National Medical Products Administration has accepted the NDA seeking approval of sovleplenib in patients with primary immune thrombocytopenia.

The European Commission has granted conditional marketing authorization to adagrasib for patients with KRAS G12C+ advanced non–small cell lung cancer.

China’s NMPA has accepted the sNDA seeking the approval of cadonilimab plus chemotherapy for use in select patients with gastric or GEJ adenocarcinomas.

Rupert Bartsch, MD, discusses findings from the final analysis of the phase 2 TUXEDO-1 trial of trastuzumab deruxtecan in patients with HER2-positive breast cancer with active brain metastases.

The European Medicines Agency has validated its marketing authorization application for repotrectinib in adult patients with ROS1 TKI-naive or -pretreated locally advanced or metastatic non–small cell lung cancer harboring ROS1 fusions, as well as adult and pediatric patients with TKI-naive and pretreated NTRK-positive locally advanced or metastatic solid tumors.

The National Medical Products Administration of China has approved sugemalimab paired with fluorouracil and platinum-based chemotherapy for use in the frontline treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The European Commission has approved new indications for pembrolizumab in combination with chemotherapy in select patients with gastric or gastroesophageal adenocarcinoma and select patients with biliary tract cancer.

Idecabtagene vicleucel has received marketing and manufacturing approval in Japan for its supplemental new drug application in patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy.

Axatilimab induced rapid and durable responses with an acceptable toxicity profile at all doses analyzed with highest efficacy observed at the 0.3-mg/kg dose in patients with recurrent or refractory chronic graft-vs-host disease.

The European Medicines Agency has validated a type II application for the investigational T-cell engaging bispecific antibody epcoritamab-bysp for patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of therapy

The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of the next-generation ROS1 TKI taletrectinib for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer with prior exposure to a ROS1 TKI.

The National Medical Products Administration of China has approved sugemalimab for use in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma.

The European Commission has approved rucaparib as first-line maintenance therapy for patients with advanced ovarian cancer, regardless of BRCA mutation status, who have responded following the completion of frontline platinum-based chemotherapy.

The European Commission has granted marketing authorization to the combination of zanubrutinib and obinutuzumab for the treatment of adult patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of systemic therapy.

China’s National Medical Products Administration has granted conditional marketing approval to vebreltinib for the treatment of patients with non–small cell lung cancer harboring MET exon 14 skipping mutations.

China’s National Medical Products Administration has approved durvalumab plus gemcitabine and cisplatin for frontline use in adult patients with locally advanced or metastatic biliary tract cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of subcutaneous atezolizumab for all indications in which the intravenous formulation is approved, including certain types of lung, liver, bladder, and breast cancer

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of momelotinib for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anemia with primary myelofibrosis, post–polycythemia vera myelofibrosis, or post–essential thrombocytopenia myelofibrosis who have not been exposed to a JAK inhibitor or who had received prior ruxolitinib.

After a re-examination procedure, the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on the conditional marketing authorization application for adagrasib in the treatment of adult patients with KRAS G12C–mutated advanced non–small cell lung cancer whose disease progressed following at least 1 prior systemic treatment.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of pembrolizumab (Keytruda) combined with gemcitabine and cisplatin in the frontline treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer

First-line treatment with the PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine led to a statistically significant improvement in overall survival vs placebo plus oxaliplatin and capecitabine in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, meeting the primary end point of the phase 3 AK104-302 trial.

The European Medicines Agency had validated a marketing authorization application seeking the approval of the combination of encorafenib and binimetinib for the treatment of adult patients with BRAF V600–mutant advanced non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of elranatamab-bcmm for the treatment of adult patients with relapsed/refractory multiple myeloma who were previously treated with 3 or more lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and who experienced disease progression on their last therapy.

The European Medicines Agency has validated a type II variation application for the first-line combination of nivolumab and cisplatin-based chemotherapy for adult patients with unresectable or metastatic urothelial carcinoma.

The European Medicines Agency has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Peter Schmid, FRCP, MD, PhD, discusses key findings from the phase 1/2 BEGONIA trial in patients with unresectable, metastatic or locally advanced triple-negative breast cancer, highlighting the clinical significance of these findings.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted conditional marketing authorization to epcoritamab-bysp monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapy.

Health Canada has approved relugolix for the treatment of men with advanced prostate cancer.

The European Commission has approved fam-trastuzumab deruxtecan-nxki for the treatment of patients with advanced non–small cell lung cancer whose tumors harbor an activating HER2 mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

The combination of amivantamab-vmjw (Rybrevant) and chemotherapy produced a median progression-free survival of 11.4 months vs 6.7 months with chemotherapy alone in patients with advanced, EGFR exon 20 insertion–positive non–small cell lung cancer.