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.
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.
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).
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.
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.
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.
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.
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.