FDA Fast Tracks CAR-T Lymphoma Med, Atrial Fibrillation Treatment


The atrial fibrillation drug, asundexian, may provide protection from thrombotic events without a corresponding increase in bleeding risk.

FDA granted fast-track designation to two promising investigational treatments — one for several B-cell lymphomas and another for prevent stroke and systemic embolism in people with atrial fibrillation (AF).

The agency fast-tracked ImmPACT Bio USA’s IMPT-314, a potential first-in-class CD19/CD20 CAR T therapy to treat patients with B-cell mediated malignancies, the company said. The malignancies included relapsed or refractory (R/R) aggressive B-cell lymphoma; diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS); high grade B cell lymphoma (HGBCL); primary mediastinal B-cell lymphoma (PMBCL); and DLBCL arising from follicular lymphoma (FL) after two or more lines of systemic therapy.

"Fast-track designation from the FDA underscores the serious unmet medical need in patients with aggressive B cell lymphomas and reinforces the differentiated therapeutic promise of IMPT-314," said Sumant Ramachandra, M.D., Ph.D., president and CEO of ImmPACT Bio. "Relapsed or refractory B cell lymphomas are aggressive malignancies that despite the availability of multiple treatment options, are limited by high rates of relapse, low survival rates or serious toxicity.”

IMPT-314 was designed to target two prevalent B cell antigens — CD19 and CD20 — to prolong durability and help overcome treatment resistance arising from antigen escape, Ramachandra said. “We believe IMPT-314 has potential to extend duration of response with a safe, well-tolerated profile that may enhance accessibility.”

The Fast Track designation is based on the results of a phase 1 UCLA investigator-led study. There was a 91% objective response rate in patients taking IMPT-314 with 73% achieving a durable complete response. Patients also had 18.2 months median progression-free survival with a median follow-up of 20.5 months. Notably, there were no neurotoxicity or immune effector cell-associated neurotoxicity syndrome and no cytokine release syndrome above Grade 1.

In the second quarter, ImmPACT Bio will begin a phase 1/2 trial in aggressive B-cell malignancies.

Bayer’s investigational drug asundexian (BAY2433334) received fast track designation as a potential treatment to prevent stroke and systemic embolism in AF. Asundexian also received fast track designation in 2022 for prevention of stroke in patients after a noncardioembolic ischemic strpole

It is estimated that up to 40% of eligible patients are either not treated with direct oral anticoagulants or are undertreated because patients perceive the risk of experiencing bleeding outweighs their need for thrombosis prevention, according to Bayer. Inhibition of FXIa by asundexian could provide protection from thrombotic events without a corresponding increase in bleeding risk.

Despite “significant advances in treatment, potential concerns of bleeding risks remain at the forefront of thrombosis management,” said Christian Rommel, member of the executive committee of Bayer AG’s Pharmaceutical Division and head of research and development. “Asundexian is currently investigated as a candidate in an entirely new class of antithrombotic treatment options aiming to selectively modulate coagulation, address patients with concerns of bleeding, and focus on indications where current anticoagulation is not used.”

The second fast-track Designation for asundexian “emphasizes the medical need to prevent stroke and systemic embolism in people diagnosed with atrial fibrillation,” Rommel added. “This designation provides an opportunity to accelerate the development of asundexian and quickly address current patient needs.”

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