FDA Review: Bayer, Daiichi Sankyo, AstraZeneca and More

FDA_Sarah Silbiger/Getty Images

Sarah Silbiger/Getty Images

Every week, the U.S. Food and Drug Administration reviews drug applications, grants various designations to drugs and medical devices and approves therapies. It’s difficult to keep up, but don’t worry, BioSpace has you covered.

Daiichi Sankyo and AstraZeneca reported Friday that the FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic non-small cell lung cancer whose tumors have activating HER2 mutations. This follows the August 6 approval of Enhertu for adults with unresectable or metastatic HER2-low breast cancer. The FDA nod is for patients who have received previous chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Guardant Health reported Friday that the FDA has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic for select patients with unresectable or metastatic HER2-mutant non-small cell lung cancer whose tumors have activating HER2 mutations for treatment with Daiichi Sankyo and AstraZeneca’s Enhertu.

Merck reported Tuesday that the FDA found contamination of some samples of its type 2 diabetes drug Januvia (sitagliptin). The contamination was nitrosamine Nitroso-STG-19 (NTTP). The agency will allow continued distribution, but the company is working to improve quality control mechanisms.

Bayer announced Monday that the FDA has approved a supplemental New Drug Application (sNDA) for its oral androgen receptor inhibitor darolutamide in combination with docetaxel for patients with metastatic hormone-sensitive prostate cancer. The approval was based on data from the Phase III ARASENS trial.

ImmVira, based in Shenzhen, China, reported that the FDA has granted its new oncolytic herpes simplex virus product MVR-C5252 Orphan Drug Designation. The therapy is targeting malignant glioma. The drug, developed on ImmVira’s OvPENS new drug development platform, is designed to achieve on-target malignant gliocyte killing while maintaining a solid safety profile.

Attralus’s 124I-AT-01 (iodine (I-124) evuzamitide) received Orphan Drug Designation from the FDA as a diagnostic for the management of transthyretin amyloidosis (ATTR). The product utilizes Attralus’s pan-amyloid binding peptide as an amyloid-specific imaging agent.

Relmada Therapeutics received Fast Track designation from the FDA for REL-1017, a novel NMDA receptor channel blocker being developed as a monotherapy for major depressive disorder. The drug is being assessed in a registrational Phase III trial in this indication. It is also being studied in two pivotal Phase III studies as a potential adjunctive treatment for MDD.

MaaT Pharma announced Wednesday that the FDA has maintained the clinical hold on MaaT013. The drug is being developed for steroid-resistant acute graft-versus-host disease. The hold will continue while the agency awaits more data on how the drug was developed.

Cure Rare Disease (CRD) received the greenlight to conduct a Phase I trial of CRD-TMH-001, a CRISPR-based therapeutic to treat muscle promoter and exon 1 mutations in the dystrophin gene for Duchenne muscular dystrophy (DMD).

Bodyport received 501(k) clearance from the FDA for its noninvasive biomarker platform, the Bodyport Cardiac Scale, which can assess measures of heart function and fluid status.

CereVasc announced the FDA has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage.

Lexaria Bioscience Corp. received a positive full written response from the FDA from its pre-IND meeting regarding DehydraTECH-CBD for the treatment of hypertension.

aTyr Pharma received Fast Track designation from the FDA for efzofitimod for pulmonary sarcoidosis, a type of interstitial lung disease. The drug is a first-in-class immunomodulator against neuropilin-2.

The Menarini Group and Stemline Therapeutics reported that the FDA has accepted their NDA for elacestrant, a selective estrogen receptor degrader for patients with ER+/HER2- advanced or metastatic breast cancer. It has been given a PDFUA date of February 17, 2023.

Aro Biotherapeutics received Orphan Drug Designation from the FDA for ABX1100, an investigational Centyrin-siRNA conjugate targeting the Gys1 gene in the muscle, for the treatment of Pompe disease.

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