Global Oncology

The China National Medical Products Administration has accepted a supplemental new drug application for zanubrutinib as a treatment option for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended to expand the current indication for avapritinib to include single-agent use in patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, or mast cell leukemia.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B following 2 or more lines of systemic therapy.

The European Commission has granted a marketing authorization for lorlatinib for use as a single agent in the treatment of adult patients with ALK-positive advanced non–small cell lung cancer who did not receive a prior ALK inhibitor.

The China National Medical Products Administration has accepted a supplemental new drug application for zanubrutinib as a treatment for adult patients with Waldenström macroglobulinemia.

The presence of Arthrobacter and fatty acid metabolism pathways in gut microbiomes may be linked to an increased risk of skin-related adverse events in patients with advanced gastric cancer who are receiving single-agent nivolumab.

The Japanese Ministry of Health, Labour, and Welfare has approved idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 3 therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have progressed on their last therapy or relapsed following their last therapy.

Nivolumab did not significantly improve overall survival compared with chemotherapy in Japanese patients with platinum-resistant ovarian cancer.

The Scottish Medicines Consortium has accepted fam-trastuzumab deruxtecan-nxki as a treatment option for adult patients with HER2-positive unresectable or metastatic breast cancer who have previously received 2 or more anti–HER2-based therapies.

The European Commission has granted conditional marketing authorization to sotorasib for the treatment of adult patients with KRAS G12C mutant advanced non–small cell lung cancer.

A new drug application seeking the approval of valemetostat tosylate for use in the treatment of patients with relapsed/refractory adult T-cell leukemia/lymphoma has been submitted to the Japanese Ministry of Health, Labour, and Welfare.

The Japanese Ministry of Health, Labour, and Welfare has approved the combination of pembrolizumab plus lenvatinib for use in patients with unresectable, advanced, or recurrent endometrial carcinoma that has progressed on chemotherapy.

The China National Medical Products Administration has granted a conditional marketing approval to selinexor for use in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have previously received treatment and whose disease is refractory to at least a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

A supplemental new drug application has been submitted to Japan’s Ministry of Health, Labour, and Welfare or the use of fam-trastuzumab deruxtecan-nxki as a treatment in select patients with HER2-positive unresectable or recurrent breast cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of single-agent pembrolizumab for use as an adjuvant treatment in adult patients with renal cell carcinoma who are at increased risk of recurrence after nephrectomy, or following nephrectomy and the resection of metastatic lesions.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of the approval of enfortumab vedotin as a monotherapy in the treatment of adult patients with locally advanced or metastatic urothelial cancer.

First-line maintenance treatment with the PARP inhibitor niraparib yielded a clinically meaningful and statistically significant improvement in progression-free survival vs placebo in Chinese patients with platinum-responsive advanced ovarian cancer, regardless of biomarker status, according to data from the phase 3 PRIME trial.

The combination of pembrolizumab and axitinib demonstrated comparable activity and safety vs sunitinib in Japanese patients vs the global population of patients with newly diagnosed metastatic renal cell carcinoma enrolled in the phase 3 KEYNOTE-426 trial.

The European Commission has approved the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced renal cell carcinoma.

The European Commission has granted an approval to the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior platinum-containing therapy in any setting and who are not eligible for curative surgery or radiation.

The European Commission granted marketing authorization for sacituzumab govitecan-hziy for use as a monotherapy in the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who have previously received 2 or more systemic therapies, at least 1 of them for advanced disease.

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.

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

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.

The European Commission has approved pembrolizumab plus chemotherapy for the frontline treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 expression combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

The European Commission has approved nivolumab plus fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors have a PD-L1 combined positive score of 5 or higher.

The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma.

Health Canada has approved infigratinib for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring a FGFR2 fusion or other rearrangement.

The investigational next-generation ROS1/NTRK inhibitor taletrectinib was found to elicit encouraging responses with an acceptable toxicity profile in patients with ROS1-positive non–small cell lung cancer, according to preliminary data from the phase 2 TRUST trial.