MedPath

FDA Accepts Shorla Oncology's NDA for Oral Liquid SH-201 in Leukemia and Other Cancers

• The FDA has accepted Shorla Oncology's New Drug Application (NDA) for SH-201, an oral liquid formulation designed to treat specific types of leukemia and other cancers. • SH-201 aims to provide an alternative treatment option for patients who lack access to an oral liquid formulation, addressing a significant unmet need in cancer therapy. • The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2024, for SH-201, indicating the timeline for the agency's decision. • SH-201 represents Shorla Oncology's second NDA acceptance in 2024, following SH-105, highlighting the company's focus on innovative oncology drugs.

Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SH-201, a palatable oral liquid formulation of a chemotherapeutic agent. This drug is intended for the treatment of certain forms of leukemia and other cancers, offering a new option for patients who may not have access to existing oral liquid treatments. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2024.

Addressing Unmet Needs in Leukemia Treatment

SH-201 is designed to slow or stop the growth of certain cancers, including Chronic Myeloid Leukemia (CML) and Acute Lymphoblastic Leukemia (ALL). According to the American Cancer Society, approximately 9,280 new patients are diagnosed with CML and 6,550 with ALL each year in the U.S. The availability of a palatable oral liquid formulation addresses a key unmet need, particularly for patients who have difficulty swallowing pills or prefer liquid medication.

Shorla Oncology's Growing Portfolio

This NDA acceptance marks Shorla Oncology's second in 2024, following the acceptance of SH-105, a ready-to-dilute formulation for adenocarcinoma of the breast or ovary. Shorla Oncology also markets Nelarabine for T-cell Leukemia and JYLAMVO, an oral methotrexate solution for acute lymphoblastic leukemia and other indications. The company recently secured $35 million in Series B funding to accelerate the growth of its oncology portfolio.

About SH-201

SH-201 is the first palatable oral liquid of its kind in the U.S. It is designed to provide a more convenient and accessible treatment option for patients with certain forms of leukemia and other cancers.

Shorla Oncology's Focus

Founded in 2018, Shorla Oncology focuses on developing innovative oncology drugs for orphan and pediatric cancers. The company targets indications where existing treatments are limited, in shortage, or inadequate for the target population. Shorla's mission is to bring accessible, affordable, and life-saving treatments to patients, contributing to improved patient care.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Expands Approval of JYLAMVO for Pediatric Use in Oncology and Autoimmune Diseases

Shorla Oncology announced the FDA's expanded approval of JYLAMVO (methotrexate) to include treatment for pediatric patients with acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis, marking it as the only oral liquid methotrexate approved for both adult and pediatric indications.

FDA Grants Priority Review to Saol Therapeutics' SL1009 for Rare Pediatric Mitochondrial Disorder

The FDA has accepted Saol Therapeutics' NDA for SL1009 (sodium dichloroacetate) with Priority Review for treating Pyruvate Dehydrogenase Complex Deficiency (PDCD).
SL1009, an oral solution, targets PDK to enhance ATP production in PDCD patients and has Orphan Drug, Fast Track, and Rare Pediatric Disease Designations.

FDA Approves Imkeldi (Imatinib) Oral Solution for Certain Leukemias and Cancers

The FDA has approved Imkeldi (imatinib) oral solution, the first liquid formulation of imatinib, for treating certain forms of leukemia and other cancers.
Imkeldi is indicated for chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), and gastrointestinal stromal tumors (GIST) in adults and children.

Daratumumab Seeks Approval for High-Risk Smoldering Multiple Myeloma

Applications have been submitted to the FDA and EMA for subcutaneous daratumumab monotherapy in high-risk smoldering multiple myeloma.
The submissions are based on data from the phase 3 AQUILA trial, with initial findings to be presented at the 2024 ASH Annual Meeting.

FDA Expands Approval of JYLAMVO (Methotrexate) for Pediatric ALL and pJIA

The FDA has expanded the approval of JYLAMVO (methotrexate) to include pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA).
JYLAMVO is now the only oral liquid methotrexate approved for both adult and pediatric indications, offering a convenient alternative to pills.

FDA Expands Approval of JYLAMVO™ (Methotrexate) for Pediatric ALL and pJIA

The FDA has expanded the approval of JYLAMVO™ (methotrexate) for pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA).
JYLAMVO™ is now the only oral liquid methotrexate approved for both adult and pediatric indications, offering a convenient alternative to pills.

FDA Grants Priority Review to Soleno's DCCR for Prader-Willi Syndrome

The FDA has accepted Soleno Therapeutics' NDA for DCCR, granting Priority Review for treating hyperphagia in Prader-Willi Syndrome (PWS) patients aged four and older.
A PDUFA target action date is set for December 27, 2024, with the FDA planning an advisory committee meeting to discuss DCCR's application.

FDA Approves Tepylute, a Ready-to-Dilute Thiotepa Formulation, for Breast and Ovarian Cancer

The FDA has approved Tepylute, a ready-to-dilute formulation of thiotepa, for treating breast and ovarian cancer, addressing limitations of the previous powder form.
Tepylute simplifies drug preparation, enhances dosing accuracy, and reduces healthcare personnel's exposure to this hazardous drug during handling.

FDA Accepts Shorla Oncology's NDA for Oral Liquid Leukemia Drug SH-201

The FDA has accepted Shorla Oncology's New Drug Application (NDA) for SH-201, an oral liquid formulation of a chemotherapy drug used to treat certain forms of leukemia.
The FDA's decision on the approval of SH-201 is expected by November 30, 2024, under the Prescription Drug User Fee Act (PDUFA).

FDA Accepts NDA for SH-105, a Ready-to-Dilute Formulation for Breast and Ovarian Cancer

The FDA has accepted a New Drug Application (NDA) for SH-105, a ready-to-dilute formulation of a treatment for breast and ovarian adenocarcinoma.
SH-105 offers clinicians and patients an easier-to-administer injectable product with unique characteristics, potentially facilitating rapid adoption upon approval.

Reference News

[1]
Shorla Oncology Announces FDA Filing Acceptance of New Drug ...
shorlaoncology.com · Apr 8, 2024

Shorla Oncology announced FDA acceptance of its NDA for SH-201, a palatable oral liquid to treat certain leukemias and c...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy