Celcuity's Upcoming Gedatolisib Submission Under RTOR Program
Celcuity's Initiative in Advanced Breast Cancer Treatment
Celcuity Inc. is poised to make a significant stride in oncology as it prepares for the submission of its New Drug Application (NDA) for gedatolisib. This initiative reflects the company’s commitment to improving treatment options for patients with HR+/HER2- advanced breast cancer. With the support of the U.S. Food and Drug Administration (FDA), Celcuity is embarking on a journey to potentially redefine treatment standards in this challenging area.
Understanding the FDA’s Real-Time Oncology Review Program
The Real-Time Oncology Review (RTOR) program established by the FDA is designed to expedite the review process for promising cancer therapies. This initiative allows companies like Celcuity to submit clinical data early in the application process, paving the way for quicker access to novel therapies for patients. By prioritizing the submission of topline efficacy and safety results, the FDA aims to enhance drug review quality while ensuring that innovative treatments reach those in need promptly.
Progress of Gedatolisib in Clinical Trials
Gedatolisib, Celcuity’s leading candidate, has demonstrated promising efficacy during clinical trials. The NDA submission is based on the results from the PIK3CA wild-type cohort of the VIKTORIA-1 Phase 3 trial, where gedatolisib was tested in combination with fulvestrant and palbociclib. These medications have showcased improved clinical outcomes, highlighting a significant reduction in disease progression or mortality risk compared to standard therapies.
Impact of Positive Trial Results
The topline results showed that the gedatolisib-triplet treatment significantly reduced the risk of disease progression or death by 76% when compared to fulvestrant alone. Additionally, an impressive median progression-free survival (PFS) of 9.3 months was achieved with the triplet therapy, marking a notable improvement in the lives of patients facing this advanced stage of cancer. Similarly, the gedatolisib-doublet treatment also proved to be a game changer, achieving a median PFS of 7.4 months.
Celcuity's Commitment to Patient Care
As a clinical-stage biotechnology company, Celcuity identifies a critical need for therapies that effectively target HR+/HER2- advanced breast cancer. The company is dedicated to developing innovative treatments that offer hope to patients who have exhausted existing options. With both Breakthrough Therapy and Fast Track designations from the FDA, gedatolisib stands at the forefront of cancer therapy.
Engagement with the FDA
Celcuity’s leadership believes that working in tandem with the FDA will expedite the submission process and enhance the therapeutic landscape for patients. Brian Sullivan, CEO of Celcuity, expressed optimism regarding the FDA's acceptance of the NDA under the RTOR program. He emphasized that the FDA's involvement highlights the urgent requirement for more effective treatment solutions in oncology.
Future Clinical Trials
In addition to VIKTORIA-1, there are also ongoing trials such as the VIKTORIA-2 study, which evaluates gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant, targeting HR+/HER2- breast cancer as a first-line treatment. These advancements not only contribute to the body of knowledge surrounding cancer therapies but also position Celcuity as a leader in developing drug candidates that pave the way for novel treatment approaches.
Conclusion
Celcuity Inc. is on a pivotal path toward enhancing treatment protocols for patients suffering from HR+/HER2- advanced breast cancer. With the anticipated NDA submission for gedatolisib and the FDA's RTOR program support, the company is poised to alleviate symptoms and improve survival rates, demonstrating its commitment to advancing oncology.
Frequently Asked Questions
What is the significance of the NDA submission by Celcuity?
The NDA submission for gedatolisib is significant as it may lead to improved treatment options for patients with HR+/HER2- advanced breast cancer, providing earlier access to this promising therapy.
How does the Real-Time Oncology Review program work?
The Real-Time Oncology Review program allows companies to submit clinical data earlier in the NDA process, facilitating a faster review and potential approval of promising cancer therapies.
What were the results of the gedatolisib trials?
The trials showed that gedatolisib, when combined with other therapies, significantly reduced the risk of disease progression or death, indicating a critical advancement in treatment efficacy.
What support has the FDA provided for gedatolisib?
The FDA has granted gedatolisib Breakthrough Therapy and Fast Track designations, indicating its potential to offer significant benefits over existing treatments.
What is the future outlook for Celcuity?
Celcuity is focused on advancing its clinical trials, expanding treatment options for patients, and collaborating with regulatory agencies to bring innovative therapies to market.
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