FDA to Evaluate New Drug Application for Unique Injectable Oncology Therapy

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The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. The NDA was given a Prescription Drug User Fee Act action date of June 29, 2024.

“This innovative drug 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,” said Orlaith Ryan, Shorla Oncology chief technical officer and cofounder, in a press release.¹

The novel therapy is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s. The ready-to-dilute liquid formulation eliminates the need for powder reconstitution, which Shorla stated will bolster the product’s efficiency and lower the risks associated with drug preparation.

Shorla Oncology, a United States-Ireland specialty pharmaceutical company, develops oncology treatments for rare, orphan, and pediatric cancers, for which there are limited current treatment options. Shorla closed an $8.3 million round of Series A funding in June 2020 and in October 2023, the company announced $35 million raised in Series B funding.^2,3

On March 13, 2023, the FDA approved Shorla’s nelarabine injection (SH-111) to treat patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.⁴

In December 2023, the company launched the first oral solution for methotrexate in the United States to treat adults 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.⁵

The more recent filing of the NDA for SH-105 may add to the company’s current oncology product offerings and provide hope to patients with these diseases, according to Shorla.

“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

1. 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

2. Shorla Pharma closes $8.3M Series A funding round. News release. Shorla Pharma. June 3, 2020. Accessed January 10, 2024. https://www.prnewswire.com/news-releases/shorla-pharma-closes-8-3m-series-a-funding-round-301069775.html

3. Shorla Oncology secures $35M Series B funding round to advance its oncology product portfolio. News release. Shorla Oncology. October 4, 2023. Accessed January 10, 2024. https://www.businesswire.com/news/home/20231004152524/en/Shorla-Oncology-Secures-35M-Series-B-Funding-Round-to-Advance-its-Oncology-Product-Portfolio

4. 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/

5. 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/