CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal For Anti-cancer Drug Osimertinib

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major AstraZeneca's proposal of the protocol amendment of the anti-cancer drug Osimertinib.

This came after the drug maker AstraZeneca presented a protocol amendment version 3.0 dated 20 November 2023 protocol No. D5169C00001. This is a study of osimertinib with or without chemotherapy as 1st line treatment in patients with mutated epidermal growth factor receptor non-small cell lung cancer (FLAURA2) (FLAURA2).

The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR).

Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based on clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer.

Osimertinib is an anticancer medication that the Food and Drug Administration approved on the 18th of April 2018 as a first-line treatment for patients having non-small cell lung cancer (NSLC), that has spread to other parts and whose tumors have epidermal growth factor receptor (EGFR) mutations.

Osimertinib preferentially binds irreversibly to mutated epidermal growth factor receptor proteins, particularly those with more common mutations in lung cancer such as L858R mutation or an exon 19 deletion. It exhibits linear pharmacokinetics; the median time to Cmax is 6 hours (range 3–24 hours).

At the recent SEC meeting for Oncology held on 5th March 2024, the expert panel reviewed the proposal for the protocol amendment. version 3.0 dated 20 November 2023 protocol No. D5169C00001 presented by the drug major AstraZeneca.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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