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 PIK3CA 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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