AstraZeneca’s Tagrisso (osimertinib) Receives NMPA’s Approval as a 1L Therapy for EGFR-Mutated Non-Small Cell Lung Cancer in China

 AstraZeneca’s Tagrisso (osimertinib) Receives NMPA’s Approval as a 1L Therapy for EGFR-Mutated Non-Small Cell Lung Cancer in China

AstraZenca’s Tagrisso (osimertinib) Receives NMPA’s Approval as a 1L Therapy for EGFR-Mutated Non-Small Cell Lung Cancer in China

Shots:

  • The NMPA’s approval follows its PR pathway and is based on P-III FLAURA study assessing Tagrisso (80mg, qd) vs EGFR-TKIs (erlotinib [150mg, qd]/gefitinib [250mg, qd]) in 556 previously untreated patients with LA/m- EGFR mutated NSCLC across 29 countries
  •  The P-III FLAURA study results: improvement in PFS (18.9 vs 10.2mos.); ORR (77% vs 69%); CR (2% vs 1%); Partial response (75% vs 68%); median DoR (17.6 vs 9.6mos.); AEs (34% vs 45%)
  • Tagrisso is an irreversible EGFR-TKI, inhibiting both EGFR-sensitizing         and EGFR T790M-resistance mutations and has received NMPA’s approval in Mar’2017 and added to the NRD list effective from Jan’2019 as 2L therapy for LA/m- EGFR T790M mutated NSCLC with a progressed disease on or after EGFR-TKI therapy

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Pharmacy Business

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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