FDA news: Colorectal, prostate cancer treatments receive fast track designations
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The FDA announced several regulatory actions the past few weeks.
Here is an overview of decisions that may be relevant to your practice.
1. The agency granted fast track designation to botensilimab (AGEN1181, Agenus) and balstilimab (AGEN2034, Agenus) for treatment of patients with nonmicrosatellite instability-high/mismatch repair-deficient metastatic colorectal cancer. The designation applies to patients who have no active liver involvement.
2. The FDA granted priority review to trifluridine/tipiracil (Lonsurf, Taiho Oncology) as monotherapy or in combination with bevacizumab (Avastin, Genentech) for treatment of adults with metastatic colorectal cancer. The designation applies to patients previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy.
3. The agency granted fast track designation to 177Lu-PNT2002 (Lantheus Holdings) for treatment of patients with metastatic castration-resistant prostate cancer. PNT2002 is a PSMA-targeted 177Lu-based radiopharmaceutical therapy that combines a PSMA-targeted ligand with the beta-emitting radioisotope no-carrier-added 177Lu.
4. The FDA granted fast track designation to ERAS-801 (Erasca) for treatment of adults with glioblastoma with EGFR alterations. ERAS-801, an orally bioavailable, small molecule EGFR inhibitor, exhibited central nervous system penetration in animal studies.
5. The agency granted supplemental biologics license application to luspatercept-aamt (Reblozyl, Bristol Myers Squibb) for first-line treatment of anemia in adults with lower- to intermediate-risk myelodysplastic syndromes.
6. The FDA granted premarket approval to xT CDx (Tempus), a companion diagnostic test for solid tumor profiling, including microsatellite instability status and companion diagnostic claims for patients with colorectal cancer.
7. The FDA granted orphan drug designation to PYX-201 (Pyxis Oncology), an antibody-drug conjugate that targets extradomain-B of fibronectin, for treatment of patients with pancreatic cancer.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
FDA grants fast track designation to facilitate development and expedite review of drugs that fill an unmet medical need in a serious condition, thus enabling the agents to reach patients sooner.
References:
- Agenus receives fast track designation for botensilimab and balstilimab in colorectal cancer (press release). Available at: https://investor.agenusbio.com/news-releases/news-release-details/agenus-receives-fast-track-designation-botensilimab-and. Published April 17, 2023. Accessed May 18, 2023.
- U.S. Food and Drug Administration accepts for priority review Taiho Oncology’s supplemental new drug application for the use of triflurdine/tipiracil (Lonsurf) in combination with bevacizumab for refractory metastatic colorectal cancer (press release). Available at: https://www.taihooncology.com/us/news/2023-04-18_toi_snda_acceptance_lonsurf_combo/. Published April 18, 2023. Accessed May 18, 2023.
- Lantheus and POINT Biopharma announce FDA grants fast track designation for 177Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer (press release). Available at: https://investor.lantheus.com/news-releases/news-release-details/lantheus-and-point-biopharma-announce-fda-grants-fast-track. Published April 24, 2023. Accessed May 18, 2023.
- Erasca granted FDA fast track designation for CNS-penetrant EGFR inhibitor ERAS-801 in patients with glioblastoma (press release). Available at: https://investors.erasca.com/news-releases/news-release-details/erasca-granted-fda-fast-track-designation-cns-penetrant-egfr. Published May 1, 2023. Accessed May 18, 2023.
- U.S. FDA accepts for priority review supplemental biologics license application and EMA validates application for Reblozyl (luspatercept-aamt) as first-line treatment of anemia in adults with lower-risk myelodysplastic syndromes (MDS) (press release). Available at: https://news.bms.com/news/corporate-financial/2023/U.S.-FDA-Accepts-for-Priority-Review-Supplemental-Biologics-License-Application-and-EMA-Validates-Application-for-Reblozyl-luspatercept-aamt-as-First-Line-Treatment-of-Anemia-in-Adults-with-Lower-Risk-Myelodysplastic-Syndromes-MDS/default.aspx. Published May 1, 2023. Accessed May 18, 2023.
- Tempus receives U.S. FDA approval for xT CDx, a NGS-based in vitro diagnostic device (press release). Available at: https://www.tempus.com/news/tempus-receives-u-s-fda-approval-for-xt-cdx-a-ngs-based-in-vitro-diagnostic-device/. Published May 1, 2023. Accessed May 18, 2023.
- Pyxis Oncology reports financial results for the first quarter 2023 and provides corporate update (press release). Available at: https://ir.pyxisoncology.com/news-releases/news-release-details/pyxis-oncology-reports-financial-results-first-quarter-2023-and. Published May 11, 2023. Accessed May 18, 2023.
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