6 FDA Cancer Approvals from August 2024

During the summer of 2024, the Food and Drug Administration (FDA) approved a handful of cancer treatments for patients with both solid and blood cancers. In August, the agency approved six more treatments, ranging from non-small cell lung cancer (NSCLC) to relapsed or refractory cutaneous T-cell lymphoma.

Here are the six recently approved cancer treatments and what patients should know about them.

Tecelra to Treat Synovial Sarcoma

Patients with surgically unremovable or metastatic synovial sarcoma who had previously received chemotherapy now have a new treatment option: Tecelra (afamitresgene autoleucel).

This accelerated approval is specifically for patients with HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P-positive disease that expresses the MAGE-A4 antigen, which is determined by an FDA-approved test.

Findings from the SPEARHEAD-1 clinical trial — which led to the approval of Tecelra — showed that the overall response rate (ORR; percentage of patients whose cancer shrunk or disappeared) in 44 patients was 43%. The researchers also found that a complete response rate was found in 4.5% of patients, meaning their cancer completely disappeared.

Voranigo for Astrocytoma or Oligodendroglioma

Voranigo (vorasidenib) is a new post-surgical drug approved for patients with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.

The approval was the first systemic therapy for this patient population with a susceptible IDH1 or IDH2 mutation. Of note, Voranigo is a type of IDH1 and IDH2 inhibitor, according to the FDA.

“Not every patient responds to this treatment, and it takes several months to find out whether there’s a benefit,” Dr. Matthias Holdhoff, co-director of the Brain Cancer Disease Group at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, said during an interview with CURE®. “Some tumors shrink, some tumors stay the same and some will continue growing. But with patients with responses, this might provide an opportunity to delay radiation.”

Presurgical and Postsurgical Imfinzi in Some With NSCLC

The FDA approved Imfinzi (durvalumab) as a presurgical and postsurgical treatment for patients with surgically removable NSCLC that is at least 4 centimeters or larger and is present in the lymph nodes with no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Before surgery, eligible patients could receive Imfinzi plus platinum-based chemotherapy, the agency noted. After undergoing surgery, patients could then receive Imfinzi alone.

The approval was based on the AEGEAN trial, a phase 3 study that included 802 patients. Interestingly, researchers could not determine the event-free survival (time until disease worsens, spreads or relapses) because not enough patients experienced disease worsening by the time data was collected.

Lazcluze plus Rybrevant for Some With NSCLC

Lazcluze (lazertinib) plus Rybrevant (amivantamab-vmj) was approved by the FDA for patients with advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.

The MARIPOSA trial led to the approval of the Lazcluze regimen, which included 1,074 patients. Researchers from the study evaluated progression-free survival (PFS; time after treatment until disease worsens or spreads). They established that the Lazcluze regimen led to statistically significant improvements, with a median PFS of 23.7 months, compared with 16.6 months in patients who received Tagrisso (osimertibib).

The trial also evaluated overall survival (OS; time from treatment until death, regardless of disease status). The OS data were not ready at the time of collection because not enough patients had died when the researchers tried to calculate the averages.

Lymphir for Relapsed or Refractory Cutaneous T-Cell Lymphoma

Patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) — a rare form of lymphoma — now have Lymphir (denileukin diftitox-cxdl) as a targeted therapy option after previously receiving at least one treatment.

The phase 3 Study 302 trial, which included 119 patients, led to the approval of Lymphir. The ORR was reported to be 36.2% in patients, with a complete response found in 8.7%.

“Lymphir is a targeted therapy,” said Dr. Francine M. Foss, director of the multidisciplinary T cell lymphoma program at Yale Cancer Center and Smilow Cancer Hospital, via email with CURE®.

“It specifically binds to and kills cells that express the interleukin-2 receptor,” Foss said. “This includes lymphoma cells such as those in CTCL, but also — and importantly — it also includes regulatory T cells that might be inhibiting the body’s natural response to cancer. Because this drug is targeted, it is not associated with many of the side effects that are seen with conventional chemotherapy drugs.”

Nikitmvo for Chronic Graft-Versus-Host-Disease

The FDA approved Niktimvo (axatilimab-csfr) as a treatment for patients with blood cancers who experience chronic graft-versus-host-disease (cGVHD) and previously received two or more lines of therapy. Of note, patients typically experience cGVHD after undergoing an allogeneic stem cell transplant (replacing patients’ damaged stem cells with healthy cells from a donor).

Researchers from the AGAVE-201 trial evaluated ORR in 79 patients who received the recommended dose of Niktimvo, which was 75% in this patient population. The median time of response was 1.5 months and the median duration of response (how long treatment lasted before disease progression, another therapy or death) was 1.9 months.

Within 12 months of patients’ initial responses, 60% of patients who achieved a response did not die or had another systemic therapy.

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