Dive Into March 2025 FDA Approvals Across Cancer Subtypes

March 2025 U.S. FDA approvals across cancer subtypes, including prostate, bladder and gastrointestinal cancers.

Over the course of March, the U.S. Food and Drug Administration (FDA) granted approval to several therapeutic agents in the field of oncology across indications including prostate cancer, bladder cancer, neuroendocrine tumors, as well as others.

Here is a list of cancer therapies approved by the regulatory agency over the last month.

Tevimbra Plus Chemotherapy Approved for Some With Esophageal Cancer

On March 4, 2025, the FDA granted approval to Tevimbra (tislelizumab-jsgr) treatment in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.

The phase 3 RATIONALE-306 trial supported the regulatory approval. The clinical trial evaluated the combination in 649 patients with unresectable, locally advanced recurrent or metastatic disease. Tevimbra treatment reportedly elicited statistically significant improvement in overall survival verses placebo and chemotherapy. Moreover, patients treated with Tevimbra had a median overall survival of 16.8 months compared with 9.6 months for patients treated with placebo, resulting in a 34% reduction in the risk of death.

Keytruda Approved for HER2+ Gastric, Gastroesophageal Junction Cancer

On March 19, 2025, the FDA gave the green light to first-line treatment with Keytruda (pembrolizumab) plus Herceptin (trastuzumab) and chemotherapy for patients with locally advanced, unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (combined positive score [CPS] of 1 or more).

The FDA approval was based on data from KEYNOTE-811, a study which evaluated in combination with Herceptin and fluoropyrimidine- and platinum-containing chemotherapy. Patients with tumors that had PD-L1 CPS greater than or equal to 1 had a median progression-free survival of 10.9 months with the investigative combination versus 7.3 months with placebo. Moreover, the median overall survival was 20.1 months and 15.7 months in these respective arms; the overall response rate was 73% and 58%, while median duration of response was 11.3 months and 9.6 months.

In the phase 3 clinical trial, 698 patients with HER2-positive advanced gastric or GEJ adenocarcinoma were enrolled, and none of these patients had been previously treated with systemic therapy for metastatic disease. Of these 698 patients 85% had tumors expressing PD-L1 with a CPS of 1 or more.

Gozellix Given Green Light for Advanced PSMA-PET Imaging in Prostate Cancer

On March 21, the regulatory agency approved the next-generation prostate-specific membrane antigen (PSMA)–PET imaging agent Gozellix (TLX007-CDx) in patients with prostate cancer. This tool is used for patients prior to receiving an injection of gallium-68 gozetotide injection, which is used in advanced PET scans to detect prostate cancer.

The newly FDA-approved imaging agent is designed to identify PSMA-positive lesions during PET scans in patients with prostate cancer who may have metastatic disease and are being considered for initial definitive treatment. It is also intended for individuals with suspected cancer recurrence based on rising prostate-specific antigen (PSA) levels. 

Cabometyx Approved for Some Neuroendocrine Tumors

On March 26, the FDA approved Cabometyx (cabozantinib) treatment for both adult and pediatric patients who are 12 years old and older. This patient group is required to have had previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET).

The phase 3 CABINET trial, which evaluated patients with pNET and epNET, was used to establish the effectiveness of this treatment approach. According to the FDA report, in those who received the investigative treatment in the pNET cohort (99 patients) had a median progression-free survival of 13.8 months versus 3.3 months with placebo. In the epNET cohort (199 patients), the median progression-free survival was 8.5 months with Cabometyx compared with 4.2 months in those treated with placebo.

Comparatively, when looking at the pNET group, the objective response rate was 18% and 0%, respectively, compared with 5% and 0% in the epNET group. Overall survival data with Cabometyx treatment were not mature in either patient group.

Imfinzi Therapy Approved in Muscle Invasive Bladder Cancer

On March 28, the FDA green lit neoadjuvant treatment with Imfinzi (durvalumab) plus gemcitabine and cisplatin, followed by single-agent, adjuvant Imfinzi following radical cystectomy. This approval was for adult patients with muscle invasive bladder cancer.

Regarding the efficacy of the treatment, it was evaluated in the phase 3 NIAGARA trial. NIAGARA, a randomized, open-label, multicenter investigation, set out to randomize patients to receive either neoadjuvant Imfinzi with chemotherapy followed by adjuvant Imfinzi after surgery or neoadjuvant chemotherapy followed by surgery alone.

Notably, the investigative combination demonstrated a statistically significant improvement in survival during the pre-specified interim analysis of the now-approved combination. In the Imfinzi and chemotherapy treatment arm, event-free survival was not reached, compared with 46.1 months in the chemotherapy alone arm. Median overall survival was not reached in either the investigative combination or chemotherapy alone arm.

Pluvicto Indication Expanded by FDA in Prostate Cancer Subset

Also on March 28, the FDA announced an expansion for the indication of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) following the initial regulatory approval of the radioligand therapy in March 2022. This expansion was made to include adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibitor therapy. These individuals may also be appropriate for delaying taxane-based chemotherapy.

According to the FDA’s announcement, adult patients with previously treated metastatic castration-resistant prostate cancer should be selected for Pluvicto based on PSMA expression in their tumors, using Locametz (gallium Ga 68 gozetotide) or another approved PSMA PET imaging agent.

The efficacy of the agent was evaluated in the multicenter, open-label PSMAfore trial, which evaluated 468 patients with PSMA-positive disease after progression and were considered suitable for delaying taxane-based chemotherapy. The radiographic progression-free survival for this patient population was 9.3 months with Pluvicto treatment versus 5.6 months in the androgen receptor pathway inhibitor therapy.

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