FDA Accepts SH-105 for Review in Breast and Ovarian Cancer

FDA Accepts SH-105 for Review in Breast and Ovarian Cancer

The FDA has announced the acceptance of a new drug application (NDA) for SH-105 to potentially treat breast and ovarian cancer.¹

The FDA assigned a Prescription Drug User Fee Act action date of June 29, 2024, for the NDA.

“This innovative drug [SH-105] will offer hospital pharmacists and patients access to a differentiated, ready to administer, injectable product with unique characteristics that’s expected to facilitate rapid adoption once approved,” Orlaith Ryan, chief technical officer and cofounder of Shorla Oncology, the manufacturers of SH-105, said in a press release.

SH-105 is a novel formulation of a well-established drug that has been used as a freeze-dried powder since the 1950s. SH-105 comes in a ready-to-dilute form; the liquid formulation eliminates the need for powder reconstitution, which Shorla contends will improve efficiency and reduce the risks associated with drug preparation.

In March 2023, the company launched nelarabine for injection (SH-111) after receiving approval from the FDA for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.²

Additionally, in December 2023, the company launched the first and only oral solution for methotrexate in the United States for the treatment of adult patients with acute lymphoblastic leukemia as part of a combination maintenance regimen; cutaneous T-cell lymphoma as a single agent or in combination with chemotherapy; relapsed/refractory non-Hodgkin lymphoma in combination with chemotherapy; rheumatoid arthritis; and severe psoriasis.³

“This is an important step in improving access to and administration of a drug that will help women suffering from breast and ovarian cancer,” Sharon Cunningham, chief executive officer and cofounder of Shorla Oncology, said in the release. “It also marks a significant milestone regarding Shorla’s efforts to bring innovative oncology products to market.”¹

References

Shorla Oncology announces FDA filing acceptance of new drug application for novel formulation to treat breast and ovarian cancer. News release. Shorla Oncology. January 9, 2024. Accessed January 10, 2024. https://www.businesswire.com/news/home/20240109305168/en/Shorla-Oncology-Announces-FDA-Filing-Acceptance-of-New-Drug-Application-for-Novel-Formulation-to-Treat-Breast-and-Ovarian-Cancer

Shorla Oncology announces U.S. FDA approval of nelarabine injection for the treatment of T-cell leukemia. News release. Shorla Oncology. March 7, 2023. Accessed January 10, 2024. https://www.businesswire.com/news/home/

Shorla Oncology & EVERSANA announce U.S. commercial launch of FDA-approved JYLAMVO, the first and only oral methotrexate solution approved in the U.S. for adults. News release. Shorla Oncology. December 19, 2023. Accessed January 10, 2024. https://www.biospace.com/article/releases/shorla-oncology-and-amp-eversana-announce-u-s-commercial-launch-of-fda-approved-jylamvo-the-first-and-only-oral-methotrexate-solution-approved-in-the-u-s-for-adults/