FDA Review: Incyte, Pfizer, Iovance and More

FDA_Sarah Silbiger/Getty Images

Sarah Silbiger/Getty Images

The FDA is keeping busy as summer winds down, with approvals, Orphan Drug Designations and other actions. Here’s what the agency has been up to this week.

August 26

Incyte announced that the FDA has approved Pemazyre (pemigatinib) for the treatment of relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangements. The drug is a selective FGFR inhibitor. The approval marks the first and only targeted treatment for this indication, Incyte stated. It is also the second approval for Pemazyre, which already has FDA authorization for adults previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement.

Inhibikase Therapeutics received the go-ahead from the FDA to launch a study of IkT-001Pro for chronic myelogenous leukemia. IkT-001Pro is a prodrug formulation of imatinib mesylate and is designed to improve the safety of Gleevec (imatinib).

Suzhou Junjing Biomedical Technology Co.’s IND for JS110 was approved by the FDA. The drug is a small molecule inhibitor of the nuclear export protein XPO1 for advanced tumors.

August 25

Iovance Biotherapeutics initiated a rolling BLA submission to the FDA for lifileucel, a tumor infiltrating lymphocyte therapy, in advanced melanoma patients. The therapy is intended for patients who have progressed on or after previous anti-PD-1/L1 therapy, are BRAF mutation positive and have previously received BRAF or BRAF/MEK inhibitor therapy.

Century Therapeutics received the green light from the FDA to proceed with its ELiPSE-1 trial of CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. CNTY-101 is an allogeneic cell therapy engineered with four complementary functionalities, including a CD19 CAR for tumor targeting, IL-15 support for enhanced persistence, Allo-Evasion technology to prevent host rejection and enhanced persistence. It also has a safety switch to eliminate the drug if necessary.

Therapeutic Solutions International filed an amendment with the FDA regarding its currently open Phase III trial. The company is requesting that eligibility be expanded to include all patients suffering from acute respiratory distress syndrome (ARDS) regardless of cause. It is currently only recruiting patients with advanced ARDS caused by COVID-19.

B.More reported the FDA approved its IND application to launch a Phase IIb trial of SYNP-101 (psilocybin) for patients with alcohol use disorder. The trial is expected to start in early 2023.

August 24

Calyptus Pharmaceuticals’s Abbreviated NDA (ANDA) for Brovana (arformoterol tartrate inhalation solution) was approved by the FDA. The drug, co-developed with VistaPharm, is indicated for the long-term, twice-daily maintenance treatment of bronchoconstriction in COPD patients, including chronic bronchitis and emphysema.

Surgalign Holdings reported FDA 510(k) clearance of the Cortera Spinal Fixation System. It will integrate the system with the HOLO Portal surgical guidance system.

Tachyon Therapeutics received the go-ahead from the FDA to initiate a Phase Ia trial of TACH101 for advanced solid tumors. The drug is a KDM4 inhibitor.

Ainos submitted an IND to the FDA for a Phase II trial of Veldona, a low-dose oral interferon-alpha formulation, for mild symptoms related to COVID-19.

August 23

Foghorn Therapeutics announced that the FDA placed a full clinical hold on a Phase I dose escalation study of FHD-286 in relapsed or refractory acute myelogenous leukemia and myelodysplastic syndrome. The drug is a BRG1/BRM inhibitor. The hold was based on a death in the study, but it has not been determined if it is related to the therapy or the disease.

Jaguar Health reported the FDA has accepted its application for review for Orphan Drug Designation for Crofelemer. The drug is being evaluated for a rare congenital diarrheal disorder, microvillus inclusion disease (MVID).

K36 Therapeutics received the green light from the FDA to run a Phase I trial of KTX-1001 in patients with relapsed and refractory multiple myeloma, enriching for patients with the t(4;14) genetic translocation. KTX-1001 is a small molecule methyltransferase inhibitor of the multiple myeloma SET domain known as MMSET.

Abbott Laboratories Proclaim Plus spinal cord stimulation system featuring FlexBurst360 therapy was approved by the FDA. The product offers pain coverage across up to six areas of the trunk and/or limbs.

Synlogic reported the FDA granted Fast Track designation to its SYNB1353 for the treatment of homocystinuria.

iECURE announced the FDA has granted Rare Pediatric Disease Designation to GTP-506. The drug is being developed to treat Ornithine Transcarbamylase (OTC) deficiency.

August 22

Pfizer was instructed by the FDA to run a clinical trial to evaluate an additional course of its antiviral combination therapy Paxlovid in people who experienced COVID-19 rebound infections. The company is expected to have initial data by Sept. 30, 2023.

Pharvaris reported the FDA has placed a clinical hold on the trials of PHA121 under two Pharvaris INDs for treatment of hereditary angioedema (HAE). The hold is based on reviews of nonclinical data.

Ocelot Bio’s OCE-205 received Orphan Drug Designation from the FDA for treatment of hepatorenal syndrome. It is currently enrolling patients in a Phase II trial of the drug in hepatorenal syndrome with acute kidney injury.

Thermedical received the green light from the FDA to run a trial for SERF ablation to treat ventricular tachycardia patients resistant to conventional treatment. SERF ablation with the Durablate catheter will be the focus of the study.

DynamiCure was cleared by the FDA to run a Phase I trial of DC-6001, a therapeutic antibody against CD93, in adults with a range of advanced cancers.

Insulet received clearance of its Omnipod 5 Automated Insulin Delivery System for children aged two years and older with Type 1 diabetes.

Minerva Neurosciences submitted a New Drug Application to the FDA for roluperidone for negative symptoms in patients with schizophrenia.

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