5 FDA Solid Tumor Approvals from Spring 2024

During the spring of 2024, the Food and Drug Administration (FDA) approved several new treatments for solid tumors. From new approvals for rare cancer types, such as small cell lung cancer (SCLC) and pediatric low-grade glioma, here’s a list of five new treatments that have been recently FDA-approved.

Imdelltra for Advanced SCLC

The FDA OKed Imdelltra (tarlatamab) as treatment for patients with advanced SCLC who have progressed on or after receiving platinum-based chemotherapy.

"The FDA’s approval of Imdelltra marks a pivotal moment for patients battling [extensive stage]-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients,” Dr. Jay Bradner, executive vice president, research and development and chief scientific officer at Amgen, the manufacturer of Imdelltra, said in the company’s news release.

Findings from the phase 2 DeLLphi-301 trial led to the approval. Of note, there was an objective response rate (ORR) of 40%, with a median time of response to treatment of 9.7 months. ORR is defined as the percentage of patients whose cancers shrink or completely disappear after treatment, the National Cancer Institute states.

Tivdak for Metastatic Cervical Cancer

Tivdak (tisotumab vedotin-tftv) was approved by the FDA for patients with recurrent or metastatic cervical cancer who progressed on or after chemotherapy.

Data from the innovaTV 301 trial led to the approval, in which 502 patients were randomly assigned among two treatment groups. Half of the patients received Tivdak, while the other half received a type of chemotherapy chosen by the researchers.

In terms of results, researchers determined that the median overall survival (OS; time patients are live before death of any cause) of 11.5 months after receiving Tivdak. The median OS in the chemotherapy group was 9.5 months, they stated.

Enhertu for Some With HER2-Positive Solid Tumors

For patients with unresectable (surgically unremovable) or metastatic HER2-positive solid tumors who previously received systemic treatment, the FDA granted an accelerated approval for Enhertu (fam-trastuzumab deruxtecan-nxki).

An accelerated approval is when a treatment is approved early because it treats serious conditions or fills an unmet need, according to the FDA.

Three trials led to the approval of the drug, including the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. According to the FDA’s alert, the ORR was 51.4% in the DESTINY-PanTumor02 trial, 52.9% in the DESTINY-Lung01 trial and 46.9% in the DESTINY-CRC02 trial.

The approval, which is the “first drug ever” for patients with different types of HER2-positive solid tumors, was quite “unprecedented,” said Dr. Sarah Sammons, medical oncologist and associate direct of the metastatic breast cancer program at Dana-Farber Cancer Institute in Boston.

Anktiva Plus BCG for Certain Bladder Cancer Subset

A combination of Anktiva (nogapendekin alfa inbakicept-pmln) and Bacillus Calmette-Guérin (BCG; vaccine to treat early-stage bladder cancer) was approved for patients with BCG-unresponsive non-muscle-invasive bladder cancer. These patients have carcinoma in situ (early cancer cells located in the inner layer of the bladder lining), with or without papillary tumors (tumor growths that are long and thin).

The approval was based on findings from the QUILT-3.032 trial. Of the 77 patients in the trial, 62% had a complete response to treatment, meaning they no longer showed signs of cancer.

Researchers also found that 58% of patients had a complete response to treatment for at least 12 months. Across 24 months, 40% of patients had a complete response, the researchers noted.

Ojemda for Pediatric Low-Grade Glioma

Patients with pediatric low-grade glioma now have a safer treatment option after the FDA approved Ojemda (tovorafenib). Eligible patients are 6 months or older and have relapsed or refractory pediatric low-grade glioma with a BRAF fusion or rearrangement or BRAF V600 mutation.

“Generally, these tumors occur in a part of the brain that you can't remove but still put the patients at high risk of problems,” Dr. Daniel Landi, pediatric neuro-oncologist at Duke Cancer Institute in Durham, North Carolina, told CURE®.

“[It’s] related to things like vision, long-term neurocognitive status, movement, strength, coordination or endocrine function from the brain,” he explained. “So the purpose of [Ojemda] is to try and limit damage while preserving a very good quality of life.”

The approval of Ojemda is considered the first approval of a systemic therapy for this patient population, according to the FDA’s alert.

“Ojemda is definitely an exciting medicine, and the pediatric low-grade glioma community is excited to have this in our arsenal,” Landi said.

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