A Look Back at FDA News from February 2023

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From the new approval for sacituzumab govitecan for a breast cancer subgroup to dostarlimab for dMMR advanced endometrial, February 2023 was an important month of FDA activity.

The month of February brought 2 drugs to the market for patients with unresectable, advanced hormone-receptor positive, HER2-negative breast cancer as well as patients with dMMR recurrent/advanced endometrial cancer.

There were also applications for FDA approval that were either submitted to or accepted by the FDA. If granted approval, these applications could bring new therapies for patients with cutaneous T-cell lymphoma, and for patients with cancer who require treatment for adverse events like radiotherapy-induced severe oral mucositis and treatment-related bone loss.

Multiple drugs in the pipeline were granted orphan drug status in February, and 1 drug was granted breakthrough therapy designation. The FDA also granted an investigational new drug application to a new drug for advanced adenocarcinoma.

Here’s a look back at the notable FDA updates from February 2023.

FDA Grants Orphan Drug Status to BEA-17 for Glioblastoma Treatment

At the start of February, the FDA also granted an orphan drug designation to the first-in-class LSD1 inhibitor, BEA-17, for the treatment of patients with glioblastoma.

FDA Approves Sacituzumab Govitecan for Unresectable, Advanced HR+/HER2- Breast Cancer

The FDA granted approval on February 2, to sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

FDA Accepts Denosumab Biosimilar BLA for Treatment-Related Bone Loss in Cancer

On February 6, the FDA accepted a biologics license application for a proposed denosumab (Prolia) biosimilar as a treatment for patients with osteoporosis and patients with cancer who have treatment-related bone loss.

FDA Approves Dostarlimab for dMMR Recurrent/Advanced Endometrial Cancer

The FDA granted approval to dostarlimab (Jemperli) on February 9, for the treatment of patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

FDA's ODAC Supports Proposed Trials for Dostarlimab in dMMR/MSI-H Locally-Advanced Rectal Cancers

On February 9, the FDA’s Oncologic Drugs Advisory Committee voted 8 to 5 in favor of the development of dostarlimab (Jemperli) for the treatment of human patients with locally advanced, treatment-naïve mismatch-repair deficient or microsatellite-instability-high rectal cancer.

FDA Places Partial Clinical Hold on Phase 1/2 VELA Trial of BLU-222 in Solid Tumors

The FDA placed a partial clinical hold on the phase 1/2 VELA trial evaluating BLU-222 in patients with solid tumors in February 10.

FDA Grants 2 Orphan Drug Designations to THIO for HCC and SCLC

On February 13, the ranted 2 orphan drug designations to the anti-cancer agent, THIO, based on preclinical efficacy of the agent for hepatocellular carcinoma and small cell lung cancer.

NDA for SGX301 to Treat Early-Stage CTCL Not Accepted by FDA

A refusal to file letter has been issued by the FDA to Soligenix, Inc. on February 14, regarding the new drug application for synthetic hypericin or SGX301 (HyBryte) for the treatment of early-stage cutaneous T-cell lymphoma.

FDA Grants Orphan Drug Designation for CT103A in R/R Myeloma

Fully human anti-BCM chimeric antigen receptor T-cell therapy, CT103A, was granted orphan drug designation from the FDA on February 14, for the treatment of relapsed and/or refractory multiple myeloma.

FDA Grants Priority Review to NDA of Avasopasem for RT-Induced Severe Oral Mucositis

On February 15, the FDA accepted for filing and granted priority review to the new drug application for avasopasem manganese (GC4419) for the treatment of radiotherapy-induced severe oral mucositis in patients with head and neck cancer who are receiving standard-of-care treatment.

FDA Grants Priority Review to BLA of Elranatamab for R/R Multiple Myeloma

The FDA granted priority review to the biologics license application for the investigational BCM CD3-targeted bispecific antibody, elranatamab, on February 22, for the treatment of patients with relapsed/refractory multiple myeloma.

FDA Greenlights BTD of a Personalized mRNA Vaccine for High-Risk Melanoma

On February 22, the FDA granted a breakthrough therapy designation to mRNA-4157/V940 in combination with pembrolizumab (Keytruda) for the adjuvant treatment of patients with high-risk melanoma following complete resection.

FDA Okays IND Application of BA3182 for Advanced Adenocarcinoma

The FDA has cleared an investigational new drug application on February 23, to evaluate BA3182 for the treatment of patients with advanced adenocarcinoma.

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