Global Oncology

The EMA’s CHMP has recommended the approval of an expanded indication for dostarlimab plus chemotherapy in primary advanced/recurrent endometrial cancer.

The EMA’s CHMP has recommended the approval of imetelstat for transfusion-dependent anemia in lower-risk myelodysplastic syndrome.

Savolitinib plus osimertinib received breakthrough therapy designation in China for pretreated, locally advanced or metastatic EGFR-positive NSCLC with MET amplification.

Belantamab mafodotin plus bortezomib/dexamethasone improved OS over daratumumab plus bortezomib/dexamethasone in relapsed/refractory multiple myeloma.

NICE has recommended the reimbursement for tebentafusp in HLA-A*02:01–positive unresectable or metastatic uveal melanoma.

Fruquintinib plus sintilimab injection has received conditional approval from the NMPA for mismatch repair–proficient advanced endometrial cancer.

Tislelizumab plus chemotherapy has been approved in Europe for first-line advanced ESCC and gastric/GEJ adenocarcinoma.

Adjuvant ribociclib plus endocrine therapy was approved in Europe for HR-positive/HER2-negative early breast cancer at high risk of recurrence.

China's NMPA has accepted a sNDA for penpulimab plus anlotinib for the first-line treatment of advanced hepatocellular carcinoma.

Health Canada has approved cilta-cel for use in patients with relapsed/lenalidomide-refractory multiple myeloma following 1 to 3 prior lines of therapy.

The NMPA has approved belzutifan for von Hippel-Lindau disease in RCC, CNS hemangioblastomas, or pNETs not requiring immediate surgery.

NX-5948 has received PRIME designation from the EMA for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Osimertinib has been recommended for approval in patients with locally advanced, unresectable, EGFR-mutant NSCLC after chemoradiation.

An NDA for lisaftoclax in relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma has been accepted for review.

Zorifertinib has received NMPA approval in the first line for EGFR-mutant advanced or metastatic non–small cell lung cancer displaying CNS metastases.

Second-line BTK inhibitors were associated with improved PFS2 and OS2 in late-relapsed mantle cell lymphoma.

The European Commission has approved mirvetuximab soravtansine for select patients with pretreated FRα-positive, platinum-resistant ovarian cancer.

The EMA’s CHMP has issued a positive opinion regarding the use of amivantamab plus lazertinib in select patients with EGFR+ non–small cell lung cancer.

The CHMP has recommended repotrectinib for ROS1-positive non–small cell lung cancer and NTRK-positive solid tumors.

The CHMP has recommended the approval of pembrolizumab plus chemotherapy for first-line unresectable non-epithelioid malignant pleural mesothelioma.

The CHMP has recommended the EU approval of isatuximab plus VRd for newly diagnosed, transplant-ineligible multiple myeloma.

Health Canada has approved momelotinib for the treatment of splenomegaly and/or disease-related symptoms in myelofibrosis with moderate-to-severe anemia.

First-line zanubrutinib generated a longer PFS in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma vs relapsed/refractory disease.

Pimicotinib improved responses compared with placebo in tenosynovial giant cell tumor.

Selumetinib led to a statistically significant and clinically meaningful improvement in ORR compared with placebo in adult patients with neurofibromatosis.

NICE issued a final guidance recommending reimbursement of avapritinib monotherapy in adult patients with ASM, SM-AHN, or mast cell leukemia.

An NDA seeking the approval of sacituzumab tirumotecan for EGFR-mutant non–small cell lung cancer is under review by the NMPA’s CDE.

First-line sugemalimab plus chemotherapy has received UK approval for metastatic NSCLC without EGFR-sensitizing mutations or ALK/ROS1/RET alterations.

FDA accepts rivoceranib/camrelizumab NDA for review in HCC, acalabrutinib triplet yields responses in untreated mantle cell lymphoma, and more from OncLive this week.

Pembrolizumab-based combinations have been approved in Europe in 2 new indications for endometrial and cervical cancer.