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CDSCO Panel Grants Novartis Protocol Amendment Proposal For Alpelisib
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novartis' protocol amendment proposal for the phase III clinical trial of Alpelisib( BYL719) in combination with Nab-paclitaxel in patients with advanced triple-negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha(PIK3CA) mutation or Phosphate and Tension Homolog Protein (PTEN) loss without PIK3CA mutation.
This came after the drug major Novartis presented Protocol Amendment version 02 dated 14 March 2023, Protocol no. CBYL719H12301.
The above study is a phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple-negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation.
Alpelisib is indicated in combination with fulvestrant to treat postmenopausal women, and men, with advanced or metastatic breast cancer. This cancer must be hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, and PIK3CAÂ mutated. The cancer must be detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Alpelisib selectively inhibits PIK3 in the PI3K/AKT kinase (or protein kinase B) signaling pathway, thereby inhibiting the activation of the PI3K signaling pathway. This results in the inhibition of tumor cell growth and survival in susceptible tumor cell populations.
At the recent SEC meeting for Oncology and Hematology on 29th and 30th November 2023, the expert panel reviewed the Protocol Amendment proposal version 02 dated 14 March 2023, Protocol no. CBYL719H12301 presented by Novartis.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751