FDA Review: ClearPoint Neuro, Oncopeptides, Iterative Scopes and More

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The U.S. Food and Drug Administration had a busy week with a range of drug approvals, advisory committee meetings and classification announcements. Here’s a look.

Sept. 23

Oncopeptides reported the FDA’s Oncologic Drugs Advisory Committee voted 14-2 against the company’s Pepaxto with dexamethasone for relapsed or refractory multiple myeloma.

Sept. 22

ClearPoint Neuro’s Swedish partner, Clinical Laserthermia Systems, received 510(k) clearance for its ClearPoint Prism Neuro Laser Therapy System to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under 3.0T MRI guidance.

Iterative Scopes and Provation announced SKOUT received 510(k) clearance for adults undergoing colorectal cancer screening or surveillance.

QT Imaging received 510(K) clearance to calculate the fibroglandular volume (FGV) of the breast and the ratio of FGV to total breast volume (TGV), which can be used to help assess breast cancer risk.

PerkinElmer’s T-Cell Select reagent kit for the automation of its T-SPOT TB test workflow for in vitro diagnostic use was approved by the FDA.

Fennec Pharmaceuticals’ Pedmark was approved for chemotherapy-induced hearing loss in patients with localized, non-metastatic solid tumors treated with cisplatin.

Spectrum Pharmaceuticals faced the brunt of largely negative briefing documents from the FDA a day ahead of the September 21-22 FDA advisory meeting over the NDA for poziotinib, being considered for non-small cell lung cancer (NSCLC).

Sept. 21

Immunitas Therapeutics received the greenlight to initiate a Phase I trial of IMT-009, a monoclonal antibody against CD161 in immuno-oncology.

Cellenkos received the go-ahead for a Phase I and Phase Ib trial of CK0803, neurotrophic allogeneic Treg cells, in amyotrophic lateral sclerosis.

Kinnate Biopharma was granted Fast Track designation for KIN-2787 for patients with BRAF Class II or III alteration-positive and/or NRAS mutation-positive stage IIb to IV malignant melanoma that is metastatic or unresectable.

Eli Lilly’s Retevmo (selpercatinib) for adults with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion was approved by the FDA.

Sept. 20

Avrobio’s AVR-RD-04, an investigational gene therapy for cystinosis, received Rare Pediatric Disease Designation.

Alterity Therapeutics received the go-ahead for a Phase II trial of ATH434 in Multiple System Atrophy (MSA), a Parkinsonian disorder.

Predicine’s PredicineCARE cfDNA Assay for cancer testing received Breakthrough Device designation.

Xpira Pharmaceuticals received the greenlight for a Phase IIa trial of psilocybin-assisted therapeutic protocols in patients with anorexia nervosa.

Verismo Therapeutics received clearance for a Phase I trial of SynKIR-110 in patients with mesothelin expressing ovarian cancer, cholangiocarcinoma and mesothelioma.

Stryker received 510(k) clearance for its OptaBlate bone tumor ablation system.

Artiva Biotherapeutics received the go-ahead from the FDA for a clinical trial of AB-201, an allogeneic HER2-targeting CAR-NK cell therapy for solid tumors in the outpatient setting.

Sept. 19

WuXi Biologics’ two Drug Substance facilities and a Drug Product facility located in Wuxi city received approval from the FDA and European Medicines Agency (EMA).

Rheonix received expanded Emergency Use Authorization (EUA) for its COVID-19 MDx Assay to include home collection using the Rheonix Laboratories COVID-19 PCR Test Saliva Home Collection Kit.

XORTX Therapeutics announced completion of its Type B Pre-phase III meeting with the FDA to advance its XRx-008 program for autosomal dominant polycystic kidney disease.

Seagen announced the FDA accepted for Priority Review its sNDA for accelerated approval for Tukysa (tucatinib) in combination with trastuzumab for adults with HER2-positive colorectal cancer who have received at least one previous treatment.

Advanced NanoTherapies received FDA Breakthrough Designation for its SirPlux Duo Drug-Coated Balloon (DCB) for coronary artery disease in vessels less than 3.0mm.

Alligator Bioscience and Aptevo Therapeutics obtained FDA approval to launch a Phase I trial of ALG.APV-527 for 5T4-expressing tumor antigens in multiple solid tumor types.

Antengene Corporation’s ATG-101, a PD-L1/4-1BB bispecific antibody, was granted Orphan Drug Designation for treatment of pancreatic cancer.

Seagen announced the FDA accepted for Priority Review its supplemental NDA for Tukysa (tucatinib) in combination with trastuzumab for adults with HER2+ colorectal cancer who have received at least one previous treatment regimen for unresectable or metastatic disease.

Sept. 17

Bluebird bio’s Skysona (eli-cel) was approved by the FDA for early, active cerebral adrenoleukodystrophy (CALD).