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Darlene Dobkowski, Managing Editor for CURE® magazine, has been with the team since October 2020 and has covered health care in other specialties before joining MJH Life Sciences. She graduated from Emerson College with a Master’s degree in print and multimedia journalism. In her free time, she enjoys buying stuff she doesn’t need from flea markets, taking her dog everywhere and scoffing at decaf.
The FDA approved several drugs in December for the treatment of diseases, including pancreatic adenocarcinoma, lung cancer, skin cancer and graft-versus-host disease.
Throughout December, the Food and Drug Administration (FDA) approved several oncology drugs for the treatment of cancers including pancreatic, lung and skin.
Here is a select list of cancer therapies approved by the FDA last month.
The FDA has approved Bizengri (zenocutuzumab-zbco), the first systemic therapy for patients with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma whose tumors have a NRG1 gene fusion and have progressed after prior systemic therapy. This accelerated approval applies to both NSCLC and pancreatic adenocarcinoma.
The eNRGy study evaluated Bizengri's effectiveness in 64 adults with advanced or metastatic NRG1 fusion-positive NSCLC and 30 adults with advanced or metastatic NRG1 fusion-positive pancreatic adenocarcinoma whose disease had progressed after standard treatment. In the NSCLC group, the objective response rate (ORR) was 33%, with a median duration of response (DOR) of 7.4 months. The pancreatic adenocarcinoma group had a 40% ORR, with a DOR ranging from 3.7 to 16.6 months.
Objective response rate: the percentage of patients with a partial or complete response to treatment.
Duration of response: the time that a patient’s tumor response to treatment without the cancer growing or spreading.
Progression-free survival: the length of time during and after treatment when a patient with cancer lives without the disease worsening.
Imfinzi (durvalumab) was approved for adults with limited-stage small cell lung cancer who have not experienced disease progression following concurrent platinum-based chemotherapy and radiation therapy.
The ADRIATIC trial showed that Imfinzi significantly improved both overall survival and progression-free survival (PFS) compared to placebo. Median overall survival was 55.9 months for patients receiving Imfinzi versus 33.4 months for those receiving placebo. Similarly, median PFS was 16.6 months with Imfinzi compared to 9.2 months with placebo.
The FDA granted approval to Unloxcyt (cosibelimab-ipdl) for the treatment of patients with locally advanced or metastatic cutaneous squamous cell carcinoma (a type of skin cancer) who are not candidates for curative surgery or radiation. Unloxcyt is a PD-L1-blocking antibody, a type of immune checkpoint inhibitor that helps the body's immune system target and destroy cancer cells.
In a clinical trial, researchers assessed the ORR and DOR to the treatment. The ORR was 47% in 78 patients with metastatic cutaneous squamous cell carcinoma and 48% in 31 patients with locally advanced disease. The median DOR was not reached in the metastatic group, indicating that the response was durable, and most patients had not experienced disease progression at the time of data analysis. Among those with locally advanced disease, the median DOR was 17.7 months.
The FDA has approved Ensacove (ensartinib) for the first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic NSCLC. This approval is specifically for patients who have not previously received an ALK inhibitor.
A 2021 study published in JAMA Oncology demonstrated that Ensacove significantly improved PFS compared to Xalkori. The median PFS with Ensacove was 25.8 months, more than double the 12.7 months observed with Xalkori.
Ryoncil (remestemcel-L-rknd) was approved for children aged two months and older with steroid-refractory acute graft-versus-host disease. This is the first mesenchymal stromal cell therapy to receive FDA approval.
By day 28 of the study, the overall response rate reached 70%, with 30% of patients achieving a complete response and 41% achieving a partial response. The median DOR was 54 days, with responses lasting from seven days to at least 159 days.
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