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Novel Colorectal Cancer Drug Duo Gets Fast Tracked by FDA


The Food and Drug Administration granted botensilimab plus balstilimab a Fast Track Designation to treat certain patients with metastatic colorectal cancer.

FDA logo on blue background

The FDA will work with the pharmaceutical company developing botensilimab and balstilimab to speed up the drug duo's review.

The novel drug combination botensilimab (AGEN1181) plus balstilimab (AGEN2034) was granted a Fast Track Designation by the Food and Drug Administration (FDA) for the treatment of patients with non-mircosatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer that has no active liver involvement, according to Agenus, the pharmaceutical company manufacturing the drugs.

According to the agency’s website, the FDA grants Fast Track Designations to promising therapies that would fill an unmet medical need. In doing so, the FDA agrees to expedite the review of the drug so that it can get to patients earlier.

“The Fast Track designation offers important benefits, including the potential eligibility for a Priority Review, and we will be working with the FDA and all key stakeholders to rapidly advance the botensilimab/balstilimab combination in colorectal cancer as well as other solid tumor indications,” Dr. Steven O’Day, chief medical officer at Agenus, said in an April 17 press release.

This indication is aimed at non-MSI-H/dMMR disease that is heavily pretreated and resistant or intolerant to fluoropyrimidine, oxaliplatin and irinotecan — all types of chemotherapies that are used to treat colorectal cancer. To be eligible, patients must have also been treated with a VEGF inhibitor, an EGFR inhibitor and/or a BRAF inhibitor, if appropriate.

Botensilimab was designed to work in tumors that are “cold,” meaning that they do not typically spark an immune response. It binds to the CTLA-4 protein receptor and primes and activates T cells, which are key in the immune response against cancer.

The drug is currently being investigated in certain patients with skin cancer, as well.

Balstiliab, however, works by inhibiting the PD-1 protein, which helps cancer cells to hide from the immune system. In doing so, the drug helps the immune system to find and kill cancer cells.

Earlier this year at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium, data were presented data from an ongoing trial that showed that among 70 pretreated patients, 23% had their tumor shrink or disappear as a result of treatment with the drug duo at an average follow-up of seven months.

Twelve months after treatment, 63% of patients were still alive, which is an improvement over the approximately 25% 12-month survival rate seen with standard of care.

"We are pleased that the FDA has granted Fast Track designation for the combination of botensilimab with balstilimab in patients with non-MSI-H colorectal cancer, recognizing the high unmet medical need in this population," O’Day said.

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