FDA Approvals for Solid Cancers in June

The Food and Drug Administration (FDA) was certainly busy in June, approving six drugs for solid cancers during the month.

Here’s what you need to know about this month’s solid tumor approvals from the FDA:

Retevmo for Some Adults and Children With Thyroid Cancer

Retevmo (selpercatinib) received traditional approval from the FDA for the treatment of adult and pediatric patients at least 2 years old with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, if radioactive iodine is appropriate.

Retevmo had previously been granted accelerated approval by the agency for patients at least 12 years old with this indication in 2020.

The efficacy of Retevmo was evaluated in the LIBRETTO-001 clinical trial, where the overall response rate (ORR; patients who responded partially or completely to treatment) was 85% among 41 pretreated patients and 96% among 24 patients who had not previously received systemic therapy. The median duration of response (DOR) was 26.7 months in the pretreated group and not estimable in the previously untreated group, meaning more than half of systemic therapy-naïve patients were still responding to treatment at the time of data collection.

Evidence was also collected from 10 pediatric and young adult patients in the LIBRETTO-121 clinical trial, which had an ORR of 60%, with 83% having a response of at least a year.

Augtyro for Children, Adults With NTRK-Positive Solid Cancers

Augtyro (repotrectinib) received accelerated approval for previously treated adults and children at least 12 years old with solid tumors with an NTRK gene fusion whose disease is locally advanced (meaning it has beyond the initial location, but not to other parts of the body) or metastatic (when the disease has spread to other body parts) where resection (surgical removal of the cancer) is likely to result in severe morbidity or health complications. To be eligible for Augtyro, patients must have no other satisfactory therapies available.

The approval was based on the results of the TRIDENT-1 clinical trial, which included 88 adults with locally advanced or metastatic NTRK gene fusion-positive solid tumors that progressed on either a prior tyrosine kinase inhibitor (TKI; 48 patients) or who did not previously receive a TKI (40 patients).

The ORR among patients who previously received a TKI was 50%, and 58% in patients who did not previously receive a TKI. The median DOR was 9.9 months in the TKI-pretreated group and not estimable in the TKI-naïve group.

Imfinzi Plus Chemo for dMMR Endometrial Cancer

Imfinzi (durvalumab) plus the chemotherapies carboplatin and paclitaxel and followed by single-agent Imfinzi was approved for adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

The approval was based on findings from the DUO-E clinical trial. Among 95 patients in the trial whose disease was dMMR (when a mutation prevents cells from fixing errors when replicating DNA), the median progression-free survival (PFS; the time a patient lives without their disease worsening) was not reached among patients treated with Imfinzi, meaning not enough patients died or experienced disease progression for the number to be calculated. PFS was seven months among patients treated with a placebo (inactive drug).

Keytruda Plus Chemo for Advanced Endometrial Cancer

Also regarding endometrial cancer, the agency approved Keytruda (pembrolizumab) plus carboplatin and paclitaxel for adults with primary advanced or recurrent endometrial carcinoma.

The approval was based on findings from the KEYNOTE-868/NRG-GY018 trial of 810 patients with advanced or recurrent endometrial carcinoma — 222 patients whose disease was mismatch repair deficient (dMMR) and 588 patients were mismatch repair proficient (pMMR).

In the dMMR cohort, the median PFS was not reached for those who received Keytruda and was 6.5 months for patients who received a placebo plus chemotherapy. In the pMMR group, the median PFS was 11.1 months in the Keytruda group, versus 8.5 months in the placebo group.

Krazati Plus Erbitux for KRAS-Mutant CRC

Krazati (adagrasib) plus Erbitux (cetuximab) were approved for patients with previously treated KRAS G12C-mutant locally advanced or metastatic colorectal cancer (CRC).

The approval is based on findings of the phase 1/2 KRYSTAL-1 clinical trial of 94 patients with KRAS G12C-mutant locally advanced or metastatic CRC that was not eligible to be surgically removed.

The confirmed ORR was 34% for patients treated with Krazati plus Erbitux, with a disease control rate (patients whose disease disappears, shrinks or stops growing after treatment) of 85.1%. The median DOR was 5.8 months and 31% of patients who responded to treatment had a DOR of at least six months.

PFS was 6.9 months for those who received Krazati plus Erbitux, while the median overall survival (OS; the time a patient lives, regardless of disease status) was 15.9 months.

Tepylute for Breast and Ovarian Cancer

Tepylute (SH-105), a ready-to-dilute form of the drug thiotepa, was approved for patients with breast or ovarian cancer.

Tepylute is a liquid form of thiotepa, a powdered drug used to treat breast, ovarian and bladder cancer, according to the Mayo Clinic. To administer thiotepa, clinicians must first mix it with a solvent or diluting agent so that it can be administered to the patient via injection.

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