FDA Action Alert: Regeneron, Spectrum and More
19 Sep 2022
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The FDA has two PDUFA dates on its calendar this week, with two extra days slotted for an advisory committee meeting to evaluate drug applications from three companies. Here's what we know.
Regeneron's Libtayo for Non-small Cell Lung Cancer and Chemotherapy
Regeneron Pharmaceuticals has a target action date of Sept. 19 for its supplemental Biologics License Application (sBLA) for its checkpoint inhibitor Libtayo (cemiplimab) in combination with chemotherapy to treat non-small cell lung cancer (NSCLC). The sBLA is for first-line treatment in advanced NSCLC.
The application was supported by data from a Phase III trial of Libtayo in combination with a physician's choice of platinum-doublet chemotherapy compared to platinum-doublet chemotherapy alone. It enrolled 466 patients whom all had locally advanced or metastatic NSCLC without regard to PD-L1 expression level or tumor histology and who had no ALK, EGFR or ROS1 mutations.
The trial was halted early after the combination showed a significant overall survival improvement compared to chemotherapy alone. The company noted that the trial was also designed to include characteristics often seen in everyday clinical practice, including squamous histology, less than 50% PD-L1 expression, and inoperable locally advanced disease not eligible for definitive chemoradiation.
FDA's Oncologic Adcom Meeting for Spectrum's Poziotinib and Others
The FDA's Oncologic Drugs Advisory Committee is meeting on Sept. 22-23 to discuss Spectrum Pharmaceuticals' New Drug Application (NDA) for poziotinib to treat locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations. The patients would be chosen based on results from an FDA-approved assay.
The advisory committee will also review the NDA for Oncopeptides' Pepaxto (Melphalan flufenamide). The drug was granted accelerated approval in combination with dexamethasone for adults with relapsed or refractory multiple myeloma who have had at least four previous lines of treatment and whose disease is refractory to at least one proteasome inhibitorproteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibodyCD38-directed monoclonal antibody. The confirmatory study, according to the FDA "demonstrated a worse overall survival and failed to verify clinical benefit."
And finally, on the second day, the committee will listen to an update on an NDA submitted by Secura Bio for Copiktkra (duvelisib) for treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two previous treatment regimens. The update will include the final overall survival data from the DUO trial as a post-marketing requirement.
Fennec's Pedmark for Platinum-Induced Ototoxicity in Kids 18 with Solid Tumors
Fennec Pharmaceuticals has a target action date of Sept. 23 for its resubmitted NDA for Pedmark, a unique formulation of sodium thiosulfate. The NDA is for the prevention of platinum-induced ototoxicity (hearing damage) in pediatric patients one month to less than 18 years of age with localized, non-metastatic, solid tumors. The drug has received both Breakthrough Therapy and Fast Track Designation.
Platinum-based chemotherapies are used for a broad range of cancers and, in childhood cancers, can cause permanent hearing loss.
The NDA was built on data from two Phase III trials, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. The COG ACCL0431 protocol evaluated kids who received intensive cisplatin therapy for various cancers, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. The SIOPEL 6 study only evaluated hepatoblastoma patients with localized tumors.
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