FDA grants priority review to cervical cancer, renal cell carcinoma therapies
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The FDA announced several regulatory actions.
Here is an overview of decisions that may be relevant to your practice.
1. The FDA granted priority review to pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy, for women with newly diagnosed high-risk, locally advanced cervical cancer.
2. The agency granted priority review to belzutifan (Welireg, Merck) — an oral hypoxia-inducible factor-2 alpha inhibitor — for treatment of adults with advanced renal cell carcinoma who previously received immune checkpoint and anti-angiogenic therapies.
3. The FDA granted priority review to odronextamab (Regeneron Pharmaceuticals) — a CD20xCD3 bispecific antibody — for treatment of adults with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma whose disease progressed on at least two prior systemic therapies.
4. The FDA granted fast track designation to KT-333 (Kymera Therapeutics) — a highly selective degrader of STAT3 — for treatment of relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell lymphoma.
5. The agency granted fast track designation to MYTX-011 (Mythic Therapeutics) — a cMET-targeting antibody-drug conjugate — for treatment of patients with non-small cell lung cancer with cMET overexpression.
6. The FDA granted fast track designation to IDE161 (Ideaya Biosciences) — a poly (ADP-ribose) glycohydrolase (PARG) inhibitor — for treatment of certain adults with advanced or metastatic hormone receptor-positive, HER2-negative breast cancer with germline or somatic BRCA1/BRCA2 mutations. The designation applies to use of the agent for patients whose disease progressed after treatment with at least one line of a hormonal therapy, a CDK4/6 inhibitor therapy and a poly (ADP-ribose) polymerase (PARP) inhibitor therapy.
7. The FDA granted orphan drug designation to resminostat (Kinselby, 4SC) — an oral histone deacetylase inhibitor — for treatment of cutaneous T-cell lymphoma.
8. The agency granted orphan drug designation to TI-168 (Baudax Bio) — a next generation factor VIII-specific T regulatory therapy — for treatment of hemophilia A with inhibitors.
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.
References:
- FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus concurrent chemoradiotherapy as treatment for patients with newly diagnosed high-risk locally advanced cervical cancer (press release). Available at: https://www.merck.com/news/fda-grants-priority-review-to-mercks-application-for-keytruda-pembrolizumab-plus-concurrent-chemoradiotherapy-as-treatment-for-patients-with-newly-diagnosed-high-risk-locally-advanced/. Published Sept. 20, 2023; Accessed Sept. 23, 2023.
- FDA accepts for priority review Merck’s supplemental new drug application for Welireg (belzutifan) in certain previously treated patients with advanced renal cell carcinoma (RCC). Available at: https://www.merck.com/news/fda-accepts-for-priority-review-mercks-supplemental-new-drug-application-for-welireg-belzutifan-in-certain-previously-treated-patients-with-advanced-renal-cell-carcinoma-rcc/. Published Sept. 19, 2023. Accessed Sept. 23, 2023.
- Odronextamab BLA for treatment of relapsed/refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) accepted for FDA priority review (press release). Available at: https://investor.regeneron.com/news-releases/news-release-details/odronextamab-bla-treatment-relapsedrefractory-follicular. Published Sept. 29, 2023. Accessed Sept. 29, 2023.
- Kymera Therapeutics receives U.S. FDA fast track designation for KT-333, a first-in-class, investigational STAT3 degrader for the treatment of relapsed/refractory cutaneous T-cell lymphoma and relapsed/refractory peripheral T-cell lymphoma (press release). Available at: https://investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-receives-us-fda-fast-track-designation-kt. Published Sept. 18, 2023. Accessed Sept. 23, 2023.
- Mythic Therapeutics receives FDA fast track designation for MYTX-011 for patients with non-small cell lung cancer (NSCLC) with cMET overexpression (press release). Available at: https://mythictx.com/2023/09/26/mythic-therapeutics-receives-fda-fast-track-designation-for-mytx-011-for-patients-with-non-small-cell-lung-cancer-nsclc-with-cmet-overexpression/. Published Sept. 26, 2023. Accessed Sept. 28, 2023.
- IDEAYA Biosciences receives fast track designation for IDE161 in a second indication for the treatment of pretreated, advanced or metastatic HR+, Her2-, BRCA1/2 mutant breast cancer (press release). Available at: https://media.ideayabio.com/2023-09-27-IDEAYA-Biosciences-Receives-Fast-Track-Designation-for-IDE161-in-a-Second-Indication-for-the-Treatment-of-Pretreated,-Advanced-or-Metastatic-HR-,-Her2-,-BRCA1-2-mutant-Breast-Cancer. Published Sept. 27, 2023. Accessed Sept. 28, 2023.
- 4SC receives orphan drug designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA (press release). Available at: https://www.4sc.com/news/4sc-receives-orphan-drug-designation-odd-for-resminostat-kinselby-in-ctcl-from-the-us-fda/. Published Sept. 27, 2023. Accessed Sept. 27, 2023.
- Baudax Bio announces orphan drug designation granted by U.S. FDA for TI-168 for the treatment of hemophilia A with inhibitors (press release). Available at: https://www.baudaxbio.com/news-and-investors/press-releases/detail/272/baudax-bio-announces-orphan-drug-designation-granted-by. Published Sept. 28, 2023. Accessed Sept. 28, 2023.
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