Global Oncology

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.

The European Commission has approved daratumumab plus bortezomib, lenalidomide, and dexamethasone in ASCT-eligible, newly diagnosed multiple myeloma.

The European Medicines Agency has recommended extended authorization for frontline tislelizumab plus chemotherapy for GEJ adenocarcinoma and ESCC.

Jorge Cortes, MD, inaugural editor-in-chief of Blood Global Hematology, details what type of research the new journal will highlight and its importance.

The CHMP issued a positive opinion recommending the approval of ribociclib plus endocrine therapy in HR+/HER2– early breast cancer at high risk of recurrence.

The South Korean Ministry of Food and Drug Safety approved selinexor plus bortezomib and dexamethasone for pretreated patients with multiple myeloma.

The European Commission has granted orphan medicinal product designation to VCN-01 for the treatment of patients with retinoblastoma.

Toripalimab has been approved in India and China’s Hong Kong Special Administrative Region for recurrent or metastatic nasopharyngeal carcinoma.

China’s CDE has granted breakthrough therapy designation to first-line sunvozertinib for EGFR exon 20 insertion mutation–positive NSCLC.

A next generation sequencing–based companion diagnostic has received marketing approval in China for sunvozertinib in EGFR exon 20–positive NSCLC.

A Type II variation application has been submitted to the EMA for subcutaneous daratumumab plus VRd in newly diagnosed multiple myeloma.

LBL-024 received breakthrough therapy designation in China for pretreated advanced extrapulmonary neuroendocrine carcinoma.

Illuccix has been approved in Canada for the selection of patients with mCRPC eligible for treatment with PSMA1-targeted radionuclide therapy.

Dual HER2 blockade with trastuzumab plus pertuzumab may serve as an effective option for hormone receptor–positive, HER2-positive metastatic breast cancer.

The European Commission has approved toripalimab in indications for nasopharyngeal carcinoma and esophageal squamous cell carcinoma.

Enfortumab vedotin plus pembrolizumab has been approved in Japan for first-line radically unresectable urothelial carcinoma.

Japan’s Ministry of Health, Labour, and Welfare approved fruquintinib in metastatic colorectal cancer following progression with chemotherapy.

The CHMP has recommended the European approval of serplulimab for the first-line treatment of extensive-stage small cell lung cancer.