Global

China’s National Medical Products Administration has accepted a supplemental new drug application seeking the approval of toripalimab plus for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma

China’s National Medical Products Administration has approved trastuzumab deruxtecan monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer who have previously received a systemic therapy in the metastatic setting or whose disease recurred during or within 6 months of adjuvant chemotherapy.

The European Commission has granted conditional marketing authorization to glofitamab for fixed-duration administration in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following 2 or more lines of systemic treatment.

China’s National Medical Products Administration has approved the new drug application for equecabtagene autoleucel for the treatment of adult patients with relapsed or refractory multiple myeloma who previously received 3 or more lines of therapy, including a proteasome inhibitor and an immunomodulatory drug.

The European Commission has granted an orphan drug designation to Temferon for the treatment of patients with glioma, joining glioblastoma multiforme in its designation.

The European Commission has approved nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable non–small cell lung cancer at high risk of recurrence with tumor cell PD-L1 expression of at least 1%.

The National Medical Products Administration in China has accepted for review a new drug application seeking the approval of repotrectinib for use in adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.

The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion regarding sacituzumab govitecan-hziy monotherapy in select patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer.

The European Medicines Agency has validated and accepted a marketing authorization application for priority review for fruquintinib for the treatment of adult patients with pretreated metastatic colorectal cancer.

China’s National Medical Products Administration has granted a breakthrough therapy designation to infigratinib for the treatment of patients with gastric cancer.

Nidia Zapata, MD, discusses the role of triplet therapy in the treatment of patients with acute myeloid leukemia.

Nidia Zapata, MD, discusses the role of triplet therapy in the treatment of patients with acute myeloid leukemia.

A survey conducted by the National Comprehensive Cancer Network Best Practices Committee found that 93% of United States cancer centers polled in the report are experiencing a shortage of carboplatin, and 70% currently have a shortage of cisplatin.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of piflufolastat 18F, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent, for use in prostate cancer detection.

The China National Medical Products Adminstration’s Center for Drug Evaluation has recommended that olverembatinib receive breakthrough therapy designation for the treatment of patients with gastrointestinal stromal tumor that is succinate dehydrogenase deficient.

A Type II variation application seeking the approval of ciltacabtagene autoleucel in adult patients with relapsed and lenalidomide-refractory multiple myeloma has been submitted to the European Medicines Agency.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab as neoadjuvant therapy in combination with platinum-based chemotherapy for patients with resectable non–small cell lung cancer at high risk of recurrence and tumor cell PD-L1 expression of at least 1%.

Japan’s Ministry of Health, Labour, and Welfare has approved quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation and as maintenance monotherapy in patients with newly diagnosed acute myeloid leukemia whose tumors harbor FLT3-ITD mutations.

The National Medical Products Administration has accepted the supplemental new drug application seeking the approval of toripalimab in combination with nab-paclitaxel in patients with untreated metastatic or recurrent triple-negative breast cancer and a PD-L1 combined positive score of at least 1.

The National Institute for Health and Care Excellence has recommended the combination of pembrolizumab and lenvatinib for use in previously treated patients with advanced or recurrent endometrial cancer whose cancer has progressed on or after platinum-based chemotherapy and who cannot have curative surgery or radiotherapy.

Roxadustat proved to be noninferior to recombinant erythropoietin alfa with regard to change in hemoglobin level from baseline to an average level during weeks 9 to 13 in patients receiving concurrent chemotherapy for non-myeloid malignancies in China, meeting the primary end point of an ongoing phase 3 trial.

China’s National Medical Products Administration has granted a breakthrough therapy designation to the KRAS G12C inhibitor IBI351 as monotherapy for previously treated patients with advanced colorectal carcinoma harboring a KRAS G12C mutation.

China’s National Medical Products Administration has approved 2 supplemental new drug applications of zanubrutinib for use in treatment-naïve adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma and Waldenström macroglobulinemia.

The European Commission has approved lisocabtagene maraleucel for the treatment of adult patients with diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Health Canada has approved the combination of cemiplimab and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer without EGFR, ALK, or ROS1 aberrations who are not candidates for definitive chemoradiation.

The European Commission has granted marketing authorization to the dual action tablet comprised of niraparib and abiraterone acetate to be administered with prednisone or prednisolone in adult patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.

A deep learning risk prediction model was able to accurately identify patients with endometrial cancer at low and high risk of distant recurrence, according to data presented during the 2023 AACR Annual Meeting.

Adjuvant treatment with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) resulted in a statistically significant and clinically meaningful improvement in recurrence-free survival vs active surveillance in patients with a high risk of hepatocellular carcinoma recurrence following curative-intent resection or ablation.

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 received 1 prior anti–HER2-based therapy.

The European Medicines Agency has granted Priority Medicines scheme designation to the personalized cancer vaccine mRNA-4157/V940 and pembrolizumab for use as adjuvant treatment in patients with high-risk, stage III or IV melanoma following complete resection.