A Milestone for Shorla Oncology

8th April 2024

Posted In: Newsflash

Shorla Oncology (‘Shorla’), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers. The Agency assigned a Prescription Drug User Fee Act (“PDUFA”) action date of November 30, 2024.

This is the second FDA Acceptance for an NDA filing by Shorla Oncology announced in 2024.

Established in 2018 by Sharon Cunningham and Orlaith Ryan, Shorla Oncology is a privately held, U.S. and Ireland-based commercial stage specialty pharmaceutical company with an advanced pipeline of innovative oncology drugs for orphan and pediatric cancers.

Sharon Cunningham, Chief Executive Officer and Co-Founder of Shorla Oncology said: “With this NDA acceptance for SH-201, we are a step closer to providing an alternative treatment to thousands of U.S. patients diagnosed with leukemia and other cancers who do not currently have the option of an oral liquid.

Submitting this drug to the FDA for review is more than just a milestone for our company, it’s an important moment for all those impacted by this disease including patients, caregivers and clinicians.”

Orlaith Ryan, Chief Technical Officer and Co-Founder of Shorla Oncology said: “The FDA’s action today ensures that Shorla is well positioned to bring this innovative oral drug to market. SH-201 addresses key areas of unmet need by providing a palatable liquid treatment option for patients suffering with cancer.”

This milestone for SH-201 follows acceptance to file announced in January of this year for SH-105, a novel, differentiated ready-to-dilute formulation for the treatment of adenocarcinoma of the breast or ovary. It is progressing through FDA review.

The company recently raised $35 million in Series B funding that has allowed Shorla to accelerate the growth of its oncology portfolio.

Last year, the company launched Nelarabine for the treatment of T-cell Leukemia and JYLAMVO, the first and only oral methotrexate solution approved in the United States for use in adults for the treatment of acute lymphoblastic leukemia and other indications.

Pictured (l-r): Co-founders of Shorla, Orlaith Ryan and Sharon Cunningham.