Recapping Every FDA Approval Announced in April for Cancer Care

During the month of April 2025, the U.S. Food and Drug Administration (FDA) announced the approval of several agents and combination therapies in the field of oncology across indications including breast cancer, ovarian cancer, nasopharyngeal carcinoma, as well as several others.

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

Opdivo Plus Yervoy in Some with Colorectal Cancer

On April 8, the regulatory agency granted approval to Opdivo (nivolumab) with Yervoy (ipilimumab) for adult and pediatric patients 12 years old and older with colorectal cancer; specifically, those with unresectable or metastatic microsatellite instability-high or mismatch repair deficient disease.

Moreover, the agency also announced at the same time its conversion of accelerated approval to a regular approval for single-agent Opdivo. This agent was approved for adult and pediatric patients 12 years old and older with metastatic microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer who have progressed on previous treatment with fluoropyrimidine, oxaliplatin and irinotecan.

The efficacy and the safety of the now FDA-approved combination was evaluated in the phase 3 CHEKCMATE-8HW trial.

Treatment with Vitrakvi For NTRK-Positive Solid Tumors

On April 10, the FDA granted full approval to treatment with Vitrakvi (larotrectinib). This approval was for patients with NTRK-positive solid tumors without a known acquired resistance mutation (when tumors are metastatic or where surgical resection is likely to result in severe morbidity). The approval also included those whose disease has no satisfactory alternative treatments or patients who have progressed following treatment,

Notably, in November 2018, the FDA first granted the agent accelerated approval. The regulatory approval was based on data from the LOXO-TK-14001, SCOUT and NAVIGATE clinical trials. These studies evaluated pediatric and adult patients with unresectable or metastatic solid tumors with an NTRK gene fusion.

Opdivo Plus Yervoy in Advanced HCC

On April 11, the agency granted approval to the investigative, first-line treatment combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) for adult patients with unresectable or metastatic hepatocellular carcinoma.

The efficacy of the combination was evaluated in the CHECKMATE-9DW trial for patients with unresectable or metastatic hepatocellular carcinoma. These individuals who participated in the trial were treated with an intravenous infusion of 1 milligram per kilogram of Opdivo with 3 milligrams per kilogram of intravenous Yervoy every three weeks for a maximum of four doses, followed by single-agent Opdivo at 480 milligrams intravenously every four weeks; this was compared with the investigator’s choice of Lenvima (lenvatinib) or Nexavar (sorafenib) monotherapy.

For those treated with the now FDA-approved combination, the median overall survival was 23.7 months versus and 20.6 months with the investigator’s choice of treatment; the objective response rates were 36.1% and 13.2%, respectively. Moreover, the complete and partial response rates for patients treated with the investigative therapy were 7% and 29% versus 2% and 11% in the control group.

Penpulimab-kcqx in Nasopharyngeal Carcinoma

On April 24, the FDA has announced that, among patients with adult patients with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma, first-line treatment of penpulimab-kcqx with cisplatin or carboplatin and gemcitabine, was granted approval. Moreover, the FDA granted approval to penpulimab-kcqx as a single agent for those with metastatic non-keratinizing nasopharyngeal carcinoma following disease progression or after platinum-based chemotherapy and at least one other prior line of therapy.

The efficacy of the investigative combination was evaluated in Study AK105-304. In the multicenter trial, 291 patients with recurrent or metastatic disease who had not been treated with prior systemic chemotherapy for recurrent or metastatic disease were evaluated and treated with either penpulimab-kcqx plus cisplatin or carboplatin and gemcitabine followed by penpulimab-kcqx or placebo with cisplatin or carboplatin and gemcitabine followed by placebo.

Ready-to-Dilute Tepylute in Breast and Ovarian cancer

Finally, on April 29, the FDA shared that treatment with 100 milligrams of Tepylute (formerly SH-105) had been approved for breast and ovarian cancers. Notably, the approval included both 100- and 15-milligrams vials of Tepylute in the United States.

This therapeutic option is a ready-to-dilute version of thiotepa, a standard drug used to treat breast and ovarian cancer. The announcement shared that the now-FDA-approved formulation has the possibility to both save time and reduce preparation errors.

Notably, thiotepa has been manufactured as a freeze-dried powder since the 1950s.

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