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.
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