The U.S. Food and Drug Administration (FDA) has taken a significant step forward in the field of oncology by accepting Shorla Oncology’s New Drug Application (NDA) for SH-105, a highly promising treatment specifically designed to target breast and ovarian cancers. This milestone marks a substantial advancement in the realm of cancer therapy, with the FDA expected to decide on its approval by June 29, 2024.
SH-105 represents an innovative approach to treatment, as it offers a ready-to-dilute liquid formulation, departing from the conventional freeze-dried powder format. This shift in formulation not only enhances efficiency but also reduces the associated risks during preparation, potentially improving patient safety and treatment administration.
Shorla Oncology, a distinguished specialty pharmaceutical company with operations in both the United States and Ireland, is at the forefront of developing treatments for rare, orphan, and pediatric cancers. Its trajectory in the oncology sector has been marked by significant achievements, including securing $8.3 million in Series A funding in June 2020 and a remarkable $35 million in Series B funding in October 2023. These financial milestones have propelled Shorla’s capacity to expand its oncology portfolio.
Pioneering Treatments and Expanding Horizons in Breast and Ovarian Cancer Care
Shorla’s portfolio includes notable successes such as the FDA’s approval of nelarabine injection (SH-111) in March 2023 for the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. Furthermore, Shorla achieved a groundbreaking milestone with the launch of the first-ever oral solution for methotrexate in December 2023, addressing multiple indications, including acute lymphoblastic leukemia and severe psoriasis.
The introduction of SH-105 into Shorla’s portfolio holds immense promise, potentially bolstering the company’s impact on the field of oncology. It provides new avenues of hope and treatment options for individuals grappling with breast and ovarian cancers, two of the most challenging malignancies. This development underscores Shorla’s unwavering commitment to addressing unmet needs in cancer treatment, harnessing innovative drug formulations to enhance patient care and improve outcomes in these complex and demanding diseases.
Resource: Pharmexec, January 11, 2024
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