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FDA Review: ClearPoint Neuro, Oncopeptides,
Iterative
Scopes and More
2022-09-23
·
BioSpace
基因疗法
抗体
孤儿药
细胞疗法
优先审批
Sarah Silbiger/Getty Images 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
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
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
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)
.
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机构
China Food and Drug Administration
Spectrum Pharmaceuticals, Inc.
Wuxi Biologics (Cayman), Inc.
[+11]
适应症
常染色体显性多囊肾病
复发性多发性骨髓瘤
冠心病
[+18]
靶点
CD161
BRAF
NRAS
[+4]
药物
美法仑氟苯酰胺
地塞米松
顺铂
[+16]
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