Global Bulletin

The marketing authorization application for oral momelotinib in myelofibrosis has been approved by the European Medicines Agency.

The European Commission’s approval of cemiplimab for recurrent or metastatic cervical cancer marks the first second-line immunotherapy option available for this patient population regardless of tumor histology.

The National Institute for Health and Care Excellence has given a positive opinion of mobocertinib as a treatment for previously treated advanced non-small cell lung cancer with EGFR exon 20 insertion mutations.

The European Commission based its approval of zanubrutinib for the management of chronic lymphocytic leukemia on data from the phase 3 SEQUOIA trial and the phase 3 ALPINE trial.

The European Commission based its approval of axicabtagene ciloleucel as a second-line therapy for patients with relapsed/refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma on the efficacy findings of the phase 3 ZUMA-7 trial.

Japan’s Ministry of Health, Labor and Welfare approved pembrolizumab for use in 4 indications, including high-risk, early-stage triple-negative breast cancer, stage IIB or IIC melanoma, adjuvant renal cell carcinoma, and recurrent/metastatic cervical cancer.

The European Commission based its approval of nivolumab/relatlimab for patients with a PD-L1 expression of less than 1% on the results of the phase 2/3 RELATIVITY-047 trial.

Olaparib and bevacizumab has been approved in China as a frontline maintenance treatment for patients with advanced homologous recombination deficiency–positive ovarian cancer based on results from the phase 3 PAOLA-1 trial.

Results from the phase 3 ASCEMBL trial led to the approval of asciminib by the European Commission for patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.

The European Commission approved olaparib as monotherapy or in combination with endocrine therapy for patients with germline BRCA1/2-mutant, HER2-negative high-risk early breast cancer.

Patients with relapsed/refractory multiple myeloma appear to benefit from treatment with teclistamab, which was given a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Patients in Europe who have multiple myeloma and have received at least 1 previous therapy can now receive treatment with selinexor plus bortezomib and low-dose dexamethasone following its full marketing authorization by the European Commission.

European patients with unresectable or metastatic HER2-positive breast cancer are now able to receive treatment with trastuzumab deruxtecan following 1 or more previous anti-HER2 regimens.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended for approval trastuzumab deruxtecan for patients with unresectable or metastatic HER2-positive breast cancer.

Patients with fully resected stage IIB or IIC melanoma can now receive treatment with pembrolizumab in the adjuvant setting following its approval by the European Commission.

Based on results from the phase 2 GEOMETRY mono-1 trial, the European Commission has approved capmatinib for patients with non–small cell lung cancer who have MET exon 14 skipping mutations, and a need for systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Results from the phase 3 AENA trial led to the United Kingdom’s Medicine and Healthcare products Regulatory Agency accepting a marketing authorization application for aumolertinib for review in patients with locally advanced or metastatic non–small cell lung cancer with activating EGFR mutations, and those with locally advanced or metastatic EGFR T790M mutation–positive non–small cell lung cancer.

Based on results of the phase 3 RATIONALE-309 trial, the China National Medical Products Administration has approved tislelizumab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal cancer.

Based on results from the phase 1/2 GO29781 trial, the European Commission has approved mosunetuzumab for adult patients with relapsed/refractory follicular lymphoma.

European patients with locally advanced or early-stage triple-negative breast cancer at high risk of recurrence can now receive treatment with neoadjuvant pembrolizumab and chemotherapy, as well as pembrolizumab monotherapy post surgery following its approval by the European Commission.

Final end point analysis of the GEMSTONE-301 trial confirmed that patients with stage III non–small cell lung cancer experienced significant clinical benefit and promising efficacy following consolidation therapy with sugemalimab monotherapy.

Pembrolizumab has been approved by the European Commission in 5 indications of solid tumors that are microsatellite instability–high or deficient mismatch repair.

Patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 can receive treatment with pembrolizumab plus chemotherapy with or without bevacizumab following approval by the European Commission.

European patients with locally advanced or metastatic urothelial cancer can now receive treatment with enfortumab vedotin following treatment with a platinum-containing regimen and a PD-(L)1 inhibitor.

The European Commission has approved tepotinib for use in patients with advanced non–small cell lung cancer with MET exon 14 skipping alterations.

The European Commission approves the use of lorlatinib for the treatment of ALK-positive advanced non–small cell lung cancer.

Pemigatinib is a new treatment option following approval from the Hong Kong Department of Health for patients with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement following progression on at least 1 prior line of therapy.

The Japan Ministry of Health, Labour and Welfare granted approval to the KRAS inhibitor sotorasib for the treatment of adults with KRAS G12C–mutated non–small cell lung cancer.

Sugemalimab showed promise in the phase 2 GEMSTONE-201 trial in a group of patients with extranodal natural killer/T-cell lymphoma; developer CStone is set to submit a new drug application for the treatment to the National Medical Products Administration of China.