Global Oncology

The EC approved glofitamab with gemcitabine/oxaliplatin for patients with relapsed or refractory diffuse large B-cell lymphoma, ineligible for ASCT.

Durvalumab received approval from Health Canada for patients with LS-SCLC whose disease has not progressed after platinum-based chemoradiation.

The European Commission approved subcutaneous daratumumab plus VRd for newly diagnosed multiple myeloma, regardless of transplant eligibility.

The European Commission has approved subcutaneous amivantamab in multiple indications in advanced EGFR-mutant non–small cell lung cancer.

Durvalumab has received perioperative approval in the European Union in patients with resectable non–small cell lung cancer based on data from AEGEAN.

The European Commission approved trastuzumab deruxtecan for HR-positive, HER2-low or -ultralow metastatic breast cancer after at least 1 endocrine therapy.

Acalabrutinib was effective in a population of patients from China with relapsed/refractory CLL.

Axi-cel led to higher response rates but increased toxicity vs tisa-cel in older patients with relapsed/refractory DLBCL.

The EMA’s CHMP has issued a positive opinion for the denosumab biosimilars Osvyrti and Jubereq for the same indications as the reference products.

Tisotumab vedotin was granted approval by the EU for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

CHMP recommends EU approval of acalabrutinib plus chemoimmunotherapy for untreated mantle cell lymphoma.

The EMA’s CHMP recommended the approval of first-line tislelizumab plus chemotherapy for extensive-stage small cell lung cancer.

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.