Global

The Center for Drug Evaluation of the China National Medical Products Administration has accepted the biologics license application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.

The European Commission has granted a full marketing authorization to luspatercept-aamt for use in adult patients with anemia associated with non–transfusion-dependent β-thalassemia.

The National Medical Products Administration of China has granted approval to tislelizumab in combination with fluoropyrimidine and platinum chemotherapy in the frontline treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with a high PD-L1 expression.

The National Medical Products Administration of China has approved the use of single-agent fam-trastuzumab deruxtecan-nxki in adult patients with unresectable or metastatic HER2-positive breast cancer who previously received 1 or more anti–HER2-based regimens.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab-rwlc in combination with platinum-based chemotherapy as frontline treatment for adult patients with advanced non–small cell lung cancer with PD-L1 expression of 1% or higher.

The European Union has approved durvalumab plus tremelimumab-actl for first-line treatment of advanced or unresectable hepatocellular carcinoma and in combination with platinum-based chemotherapy in metastatic non–small cell lung cancer, according to a news release from AstraZeneca.

The European Commission has approved the tablet formulation of acalabrutinib for the treatment of adult patients with chronic lymphocytic leukemia.

The FDA has granted a priority review to the biologics license application for elranatamab for the treatment of patients with relapsed/refractory multiple myeloma.

Toripalimab plus nab-paclitaxel demonstrated a significant improvement in progression-free survival compared with placebo and nab-paclitaxel in PD-L1–positive patients with stage IV or recurrent/metastatic triple-negative breast cancer.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted full marketing authorization for selinexor in combination with bortezomib and low-dose dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior therapy.

The United Kingdom’s National Institute for Health and Care Excellence has issued draft guidance supporting the use of axicabtagene ciloleucel for adults with diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma following at least 2 previous lines of systemic therapy.

Fam-trastuzumab deruxtecan-nxki has received approval in the European Union as a single agent for the treatment of patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

The Medicines and Healthcare Products Regulatory Agency has approved zanubrutinib in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia and the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20–based therapy.

The National Medical Products Administration of China has approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations and whose disease progressed on or following platinum-based chemotherapy.

The European Commission has issued an orphan drug designation to duvelisib for the treatment of adult patients with peripheral T-cell lymphoma.

The Center for Drug Evaluation of China's National Medical Products Administration has granted a breakthrough therapy designation to IBI351 for the treatment of patients with advanced non–small cell lung cancer harboring a KRAS G12C mutation who have received at least 1 prior line of systemic therapy.

Japan’s Ministry of Health, Labor, and Welfare has approved acalabrutinib for the treatment of previously untreated patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.

Japan has approved durvalumab monotherapy and durvalumab plus tremelimumab for unresectable hepatocellular carcinoma, durvalumab plus tremelimumab and chemotherapy for unresectable, advanced, or recurrent non–small cell lung cancer, and durvalumab plus chemotherapy for curatively unresectable biliary tract cancer.

The European Medicines Agency has validated an application for the use of trastuzumab deruxtecan for adults with previously treated unresectable or metastatic non–small cell lung cancer whose tumors have activating HER2 mutations.

Japan’s Ministry of Health, Labor and Welfare has approved axicabtagene ciloleucel for the initial treatment of patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, and high-grade B-cell lymphoma.

The United Kingdom’s National Institute for Health and Care Excellence has endorsed trastuzumab deruxtecan for use within the Cancer Drugs Fund for adult patients with HER2-positive, unresectable or metastatic breast cancer following at least 1 anti-HER2 treatment.

Durvalumab monotherapy failed to elicit a statistically significant improvement in overall survival vs platinum-based chemotherapy as frontline treatment in patients with stage IV non–small cell lung cancer with at least 25% positivity of PD-L1 on tumor cells, or in a subgroup of patients at low risk of early mortality.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has accepted a marketing authorization application seeking approval for sugemalimab plus chemotherapy as first-line treatment for patients with metastatic non–small cell lung cancer.

The European Commission has approved fam-trastuzumab deruxtecan-nxki as monotherapy for the treatment of patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval for the use of trastuzumab deruxtecan monotherapy for adults with unresectable or metastatic HER2-low breast cancer.

Daiichi Sankyo has filed a supplemental new drug application with Japan’s Ministry of Health, Labor, and Welfare for the use of fam-trastuzumab deruxtecan-nxki in adults with previously treated HER2-mutant unresectable advanced or recurrent non–small cell lung cancer.

The European Commission has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition, for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.

Long-term clinical data failed to show a benefit of neoadjuvant olaparib (Lynparza) plus paclitaxel vs carboplatin plus paclitaxel in patients with HER2-negative early breast cancer with homologous recombination deficiency.

Neoadjuvant treatment with nivolumab (Opdivo) plus platinum doublet chemotherapy showed superior major pathological response rates and pathological complete response rates compared with nivolumab monotherapy among patients with resectable non–small cell lung cancer even for patients with a PD-L1 expression of 50% or greater.

Using circulating tumor cell count as a guide to first-line treatment, either with chemotherapy or endocrine therapy, resulted in an improvement in overall survival compared with physician’s choice of treatment without CTC count for patients with metastatic, hormone receptor–positive/HER2-negative breast cancer.