Global Bulletin

Data from the phase 3 OCEAN trial and others support the expanded approval for melflufen in patients with previously treated multiple myeloma.

Israel approved nogapendekin alfa inbakicept plus BCG for BCG-unresponsive NMIBC with CIS, expanding access beyond the US, UK, EU, Saudi Arabia, and UAE.

The European Commission approved adjuvant T-DXd for HER2-positive early breast cancer with residual invasive disease based on DESTINY-Breast05 data.

The European Commission approved the pembrolizumab-based regimen for resectable MIBC regardless of cisplatin eligibility based on the KEYNOTE-B15 data.

Data from the phase BRUIN CLL-313 and BRUIN CLL-314 trials support the approval of pirtobrutinib for patients with CLL or SLL in China.

Health Canada approved epcoritamab plus lenalidomide and rituximab for relapsed/refractory grade 1 to 3a follicular lymphoma, backed by the EPCORE FL-1 trial.

Data from the phase 3 MK-3475A-D77 trial support the Japanese approval of subcutaneous pembrolizumab and berahyaluronidase alfa.

A positive CHMP opinion supports the perioperative use of pembrolizumab plus enfortumab vedotin in resectable MIBC regardless of cisplatin eligibility.

T-DXd and Dato-DXd are now approved treatments in Japan for patients with breast cancer.

NICE recommended trastuzumab deruxtecan for reimbursement in England for HER2-low metastatic breast cancer, backed by DESTINY-Breast04 data.

Japan’s MHLW approved sevabertinib for HER2-mutant advanced or recurrent NSCLC across all lines of therapy based on phase 1/2 SOHO-01 data.

The European Commission based its approval of teclistamab plus daratumumab for relapsed/refractory multiple myeloma on data from the MajesTEC-3 study.

The European Medicines Agency has begun a phased review of daraxonrasib for pancreatic cancer as the FDA nears completion of a rolling new drug application submission.

The European Commission approved epcoritamab/R2 for adult patients with relapsed/refractory follicular lymphoma based on the phase 3 EPCORE FL-1 data.

The CHMP recommended pirtobrutinib in chronic lymphocytic leukemia based on data from the phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials.

The CHMP’s recommendation for approving teclistamab plus daratumumab in this multiple myeloma population is based on data from the phase 3 MajesTEC-3 study.

Findings from the phase 2 MOR208C203 trial and phase 1b/2 INCMOR 0208-102 trial support the Japanese regulatory decision for tafasitamab in DLBCL.

Findings from the phase 3 EV-303 trial evaluating the enfortumab-based regimen vs surgery alone in this MIBC group supported the regulatory decision.

The clearance enables the developers to include China-based centers in an ongoing phase 1a/1b trial evaluating the agent in late-stage solid tumors.

The approval of the on-body injector in multiple myeloma follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use.

Data from the phase 3 DeLLphi-304 trial support the European Commission’s approval of tarlatamab in extensive-stage small cell lung cancer.

Orelabrutinib is now available in Australia for patients with relapsed/refractory mantle cell lymphoma.

The European Medicine Agency’s CHMP has adopted a positive opinion for encorafenib plus cetuximab and mFOLFOX6 in this treatment-naïve mCRC population.

Data from the phase 3 DREAMM-7 trial support the approval of belantamab mafodotin plus bortezomib and dexamethasone for patients in China.

Data from the POD1UM-303/InterAACT-2 trial support the approval of the retifanlimab regimen in first-line squamous cell carcinoma of the anal canal.

The marketing authorization was based on results from the DESTINY-Breast09 trial assessing T-DXd/pertuzumab in first-line HER2+ metastatic breast cancer.

Data from the QUILT-3.032 trial supported the Saudi approval of nogapendekin alfa plus BCG in adults with BCG-unresponsive NMIBC with carcinoma in situ.

The Taiwan FDA has approved nivolumab/ipilimumab for patients with MSI-H/dMMR metastatic colorectal cancer based on data from CheckMate 8HW.

Data from the QUILT-3.055 and QUILT-2.023 studies support the accelerated approval of the nogapendekin alfa inbakicept regimens in Saudi Arabia.

Data from the phase 3 MANUEVER trial support the approval of pimicotinib for patients in China with symptomatic tenosynovial giant cell tumors.