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China’s NMPA has granted priority review to the NDA for savolitinib plus osimertinib in pretreated EGFR-mutated advanced NSCLC with MET amplification.

The European Commission has approved a type II variation extended indication for lazertinib plus amivantamab in frontline EGFR-mutated NSCLC.

Here is your snapshot of all therapeutic options greenlit by the FDA in December 2024 spanning tumor types.

European approval is no longer being sought for Dato-DXd in advanced nonsquamous non–small cell lung cancer.

Nivolumab plus ipilimumab has been approved in Europe for the frontline treatment of adult patients with MSI-H or dMMR metastatic colorectal cancer.

The FDA awards accelerated approval to encorafenib regimen in BRAF V600E+ CRC, ensartinib wins approval in ALK+ non–small cell lung cancer, and more.

China's NMPA has approved taletrectinib for locally advanced or metastatic ROS1-positive non–small cell lung cancer after a previous ROS1 TKI.

Uproleselan plus chemotherapy did not improved overall survival in relapsed/refractory acute myeloid leukemia.

Johnson & Johnson has submitted a type II variation application to the EMA seeking the approval of ibrutinib plus R-CHOP in ASCT-eligible frontline MCL.

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.

Jame Abraham, MD, of Cleveland Clinic, and Rena D. Callahan, MD, of UCLA, sit down with Chandler Park, MD, FACP, to discuss the latest abstracts in breast cancer presented during the 2024 San Antonio Breast Cancer Symposium.

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

Prithviraj Bose, MD, of The University of Texas MD Anderson Cancer Center, and Javier Pinilla Ibarz, MD, PhD, of Moffitt Cancer Center, sit down with Chandler Park, MD, FACP, to discuss the latest in myeloproliferative neoplasms and chronic lymphocytic leukemia, respectively, from the 2024 ASH Annual Meeting.

Eunice Wang, MD, of Roswell Park Comprehensive Cancer Center, sits down with Chandler Park, MD, FACP, to discuss the latest in acute myeloid leukemia from the 2024 ASH Annual Meeting.

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.