FDA has granted Shorla Oncology’s second FDA acceptance for a New Drug Application (NDA) for SH-201, the first palatable oral liquid form of a chemotherapeutic agent designed to treat leukemia and other cancers.
The success of SH-201 was built upon Shorla’s previous FDA acceptance of the NDA filing for SH-105, a novel formulation for treating adenocarcinoma of the breast or ovary.
Sharon Cunningham, CEO of Shorla Oncology, emphasized the NDA acceptance for SH-201, highlighting that it supported Shorla’s mission to provide alternative treatment options for thousands of U.S. patients diagnosed with leukemia and other cancers.
She acknowledged that SH-201 acceptance represented a promising step forward, emphasizing its importance for patients, caregivers, and clinicians alike.
She highlighted SH-201’s FDA submission as a milestone for Shorla, emphasizing their commitment to addressing the unmet needs of leukemia and other cancers.
Orlaith Ryan, CTO of Shorla Oncology, acknowledged the acceptance of the FDA’s action, ensuring the company was well-positioned to bring SH-201 to market.
Ryan emphasized that SH-201, a promising palatable liquid treatment option, supported key areas of unmet need for cancer patients.
This development, SH-201, highlighted the dedication and progress in addressing critical challenges in leukemia and other cancer treatments.
Source: Shorla Oncology Announces FDA Filing Acceptance of New Drug Application to Treat Certain Forms of Leukemia and Other Cancers
https://www.businesswire.com/news/home/20240408742912/en/Shorla-Oncology-Announces-FDA-Filing-Acceptance-of-New-Drug-Application-to-Treat-Certain-Forms-of-Leukemia-and-Other-Cancers
