Global Oncology

Meta: The CHMP has recommended the European approval of subcutaneous nivolumab in solid tumors.

The EMA’s CHMP has recommended the approval of perioperative nivolumab plus chemotherapy in resectable PD-L1–positive non–small cell lung cancer.

Tisotumab vedotin has received Japanese approval for advanced cervical cancer following chemotherapy.

The investigational new drug application for the RDC SKB107 for the management of solid tumor bone metastases has been approved in China.

Olvi-vec plus chemotherapy led to disease control in extensive-stage small cell lung cancer that was relapsed/refractory to platinum chemotherapy.

A Type II variation application has been submitted to the EMA for the expanded approval of sugemalimab for unresectable stage III NSCLC.

The combination of toripalimab and bevacizumab has been approved in China for the treatment of patients with unresectable or metastatic HCC.

Second-line fruquintinib plus sintilimab improved PFS, ORR, and DOR outcomes vs everolimus or axitinib monotherapy in advanced/metastatic RCC.

HER2DX aided in HER2+ breast cancer therapy decisions and the pCR rate was comparable among those who did and did not have HER2DX-driven treatment changes.

Penpulimab received NMPA approval for first-line use with chemotherapy in recurrent or metastatic nasopharyngeal carcinoma.

The European Commission approved durvalumab for limited-stage small cell lung cancer without disease progression following chemoradiation.

Vepdegestrant boosts PFS in select ESR1-mutated breast cancer, maintenance OSE2101 combination provides survival benefit in PDAC, and more from OncLive.

The European Commission has approved liso-cel in relapsed/refractory follicular lymphoma after at least 2 prior lines of systemic therapy.

A BLA has been accepted in China seeking the approval of tisotumab vedotin for metastatic cervical cancer that has progressed on or after systemic therapy.

The European Commission has approved imetelstat for the treatment of patients with transfusion-dependent anemia in lower-risk myelodysplastic syndrome.

Amivantamab plus lazertinib was approved in Canada for first-line EGFR-mutated locally advanced or metastatic non–small cell lung cancer.

The Chinese NMPA has approved sacituzumab tirumotecan for EGFR-mutant advanced NSCLC following progression on an EGFR TKI and chemotherapy.

China’s NMPA has accepted an MAA seeking the approval of foritinib for ALK-positive advanced non–small cell lung cancer.

Nivolumab plus ipilimumab was approved by the European Commission for first-line, unresectable or advanced HCC.

First-line olverembatinib plus low-intensity chemotherapy has received breakthrough therapy designation in China for patients with Ph-positive ALL.

NOMA has approved the PET imaging agent for the identification of PSMA-positive lesions in patients with prostate cancer.

Regina Barragan-Carrillo, MD, discusses a study of RCC clinical trial availability and barriers to opening RCC clinical trials in lower-income countries.

The CHMP has recommended the approval of perioperative durvalumab plus neoadjuvant chemotherapy for patients with resectable NSCLC.

The CHMP has recommend the approval of subcutaneous daratumumab plus VRd for newly diagnosed multiple myeloma.

CHMP has recommended glofitamab plus gemcitabine and oxaliplatin for R/R DLBCL.

The CHMP has recommended the European approval of pirtobrutinib for relapsed/refractory CLL previously treated with a covalent BTK inhibitor.

The CHMP has issued a positive opinion for linvoseltamab in relapsed/refractory multiple myeloma.

The CHMP has recommended the approval of trastuzumab deruxtecan for HER2-low or HER2-ultralow metastatic breast cancer.

China’s NMPA has granted priority review to an NDA for neoadjuvant ipilimumab injection plus sintilimab in MSI-H or dMMR colon cancer.

Isatuximab plus VRd has been approved in Japan for transplant-ineligible, newly diagnosed multiple myeloma.