Drug Approval | November 22, 2021
European Commission approves Roche’s Gavreto
Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC
Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC
Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline
Positive results reinforce the improved efficacy seen with Opdivo-based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma
The company plans to submit the IND application by the end of 2021
The CASPIAN Phase III trial in extensive-stage small-cell lung cancer is the longest survival follow-up ever reported for immunotherapy treatment in this setting
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations
The product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients
The receipt of this permission paves way for the launch of Osimertinib 40mg/80mg film coated tablets in India.
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