5 FDA Approvals for Solid Tumors in Early 2024

From January to March 2024, the Food and Drug Administration (FDA) has approved more than 15 therapies with treatment combinations for several cancer types.

A handful of approvals were specifically for cancer types in the advanced and metastatic setting, including advanced cervical cancer, and metastatic bladder and esophageal cancers.

Here are five recent FDA approvals for solid tumors from the first quarter of 2024.

Keytruda Plus Chemoradiotherapy in Advanced Cervical Cancer

The treatment combination of Keytruda (pembrolizumab) and chemoradiotherapy was approved in January 2024 for patients with stages 3 to 4A cervical cancer.

This approval was based on results from the KEYNOTE-A18 randomized trial. It included 1,060 patients with cervical cancer who did not undergo definitive surgery, radiation or systemic therapy.

The progression-free survival was superior in the group who received the Keytruda-chemoradiotherapy regimen, compared with the placebo group. Progression-free survival is the time from the start of treatment until patients experience disease progression or death, as defined by the National Cancer Institute.

“There was an improvement in progression-free survival for the groups that got the [Keytruda], there was a 30% decrease in progression for those individuals that got the combination [of Keytruda and chemotherapy],” said Dr. Linda Duska of the University of Virginia Health.

Balversa in Metastatic Bladder Cancer

Also in January, the FDA approved Balversa (erdafitinib) to treat patients with locally advanced or metastatic bladder cancer. Specifically, the drug was approved for patients who have susceptible FGFR3 genetic alterations.

Findings from the Study BLC3001 Cohort 1 trial led to the approval, which included 266 patients with metastatic bladder cancer and FGFR3 alterations. Patients in the trial had previously received one or two lines for systemic therapy, including PD-1 or PD-L1 inhibitors.

The median overall survival (length of time from diagnosis or start of treatment when patients live with their cancer) was reported to be 12.1 months in patients who received Balversa. It was compared with a median overall survival of 7.8 months in patients who received chemotherapy.

“Balversa represents an additional option for patients [with FGFR2 and 3 mutations], and the response rates to Balversa are quite good in comparison to the use of chemotherapy,” Dr. Alexander Helfand of Allegheny Health Network previously told CURE®.

Amtagvi TIL Therapy for Advanced Melanoma

The FDA approved Amtagvi (lifileucel) — a tumor-infiltrating lymphocyte (TIL) therapy — for patients with advanced melanoma in February. The drug was specifically approved for patients with advanced melanoma who were pretreated with anti-PD-1/PD-L1 therapy and targeted therapy but experienced progression.

A global trial led to the approval of Amtagvi, in which the goal of the trial was to determine the objective response rate (ORR), or the percentage of patients whose tumors shrank or disappeared.

At an average time to response of 1.5 months, the ORR was 31.5% in 73 patients who received Amtagvi, according to the study.

Rybrevant Plus Chemotherapy for EGFR-Positive Lung Cancer

Rybrevant (amivantamab-vmjw) with chemotherapy was approved by the FDA for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The approval came through in March, specifically for patients with NSCLC who have EGFR exon 20 insertion mutations.

Data and results from the PAPILLION trial led to the approval of Rybrevant plus chemotherapy. Patients who received the regimen had a median progression-free survival of 11.4 months versus 6.7 months in patients who received chemotherapy alone.

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“This is one of the [most] groundbreaking approvals that we have for patients with EGFR exon 20 insertion mutations, [with] more to come in this field,” said Dr. Chul Kim of the Georgetown Lombardi Comprehensive Cancer Center. “The treatment landscape will likely change quite significantly in the next few years for patients, so I remain hopeful.”

Tevimbra for Unresectable Metastatic Esophageal Cancer

For patients with unresectable or metastatic esophageal squamous cell carcinoma, Tevimbra (tislelizumab) was approved by the FDA in March. Eligible patients for this treatment were previously treated with systemic chemotherapy but not a PD-1 or PD-L1 inhibitor.

Tevimbra is shown to be less toxic than chemotherapy and now offers “more options for patients,” according to Dr. Syma Iqbal of Keck School of Medicine and Norris Comprehensive Cancer Center.

The approval of Tevimbra was based on the findings from the phase 3 RATIONALE 302 trial. Data from the study demonstrated that patients lived longer when receiving Tevimbra, compared with chemotherapy. The median overall survival was 8.6 months in patients who received Tevimbra and 6.3 months in patients receiving chemotherapy alone.

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