RYBREVANT (amivantamab-vmjw) + LAZCLUZE (lazertinib) show strong favorable OS trend versus osimertinib in EGFR-mutated advanced lung cancer September 10, 2024
European Commission approves RYBREVANT (amivantamab) + chemo for adult patients with advanced EGFR-mutated NSCLC after failure of prior therapy September 3, 2024
RYBREVANT (amivantamab-vmjw) + LAZCLUZE (lazertinib) approved in the U.S. for patients with EGFR-mutated advanced lung cancer August 27, 2024
TROP2-ADC SKB264 (sac-TMT) Second NDA Accepted by NPMA for locally advanced or metastatic EGFR-mutant NSCLC August 27, 2024
CHMP recommends RYBREVANT + chemo for the treatment of adult patients with advanced EGFR-mutated NSCLC after failure of prior therapy July 30, 2024
Tagrisso + chemo approved in the EU as new 1L treatment for patients with EGFR-mutated advanced lung cancer July 9, 2024
Tagrisso + chemo approved in China & Japan as 1st-line treatment for patients with EGFR-mutated advanced lung cancer July 1, 2024
Tagrisso granted Priority Review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer June 18, 2024
Tagrisso with the addition of chemo recommended for approval in the EU by CHMP for patients with EGFR-mutated advanced lung cancer June 11, 2024
Tagrisso + chemo showed favourable trend in OS in EGFR-mutated advanced lung cancer with further follow-up in FLAURA2 Ph 3 trial March 26, 2024
Tagrisso with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer February 26, 2024
Tagrisso demonstrated efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung cancer in LAURA Ph 3 trial February 26, 2024
Type II Extension of Indication Application to the EMA Seeking Approval of RYBREVANT + Lazertinib, for 1L Treatment of Patients with EGFR-Mutated NSCLC February 26, 2024
Application submitted to the EMA for RYBREVANT + Chemo for the Treatment of Adult Patients with Advanced EGFR-Mutated NSCLC After Failure of Prior Therapy December 11, 2023
Supplemental BLA submitted to FDA Seeking Approval of RYBREVANT + Chemo in EGFRm NSCLC Patients Who Progressed on or after Osimertinib December 4, 2023
Tagrisso plus chemo granted Priority Review in the US for patients with EGFR-mutated advanced NSCLC October 25, 2023
EXKIVITY® (mobocertinib) to be voluntary withdrawn from the U.S. for adult patients with EGFR Exon20 insertion+ mNSCLC whose disease has progressed on or after platinum-based chemotherapy October 11, 2023
Ph 3 MARIPOSA Study Meets Primary Endpoint of PFS for RYBREVANT (amivantamab-vmjw) + Lazertinib vs Osimertinib in EGFR-Mutated NSCLC October 3, 2023
Patritumab Deruxtecan Demonstrated Clinically Meaningful and Durable Responses in Patients with EGFR-Mutated mNSCLC in HERTHENA-Lung01 Ph 2 Trial September 19, 2023
Ph 3 MARIPOSA-2 Study Meets Dual Primary Endpoint Resulting in PFS Improvement with RYBREVANT + Chemo +/- Lazertinib vs chemo Alone in Patients with EGFR-Mutated NSCLC after Disease Progression on Osimertinib September 13, 2023
Tagrisso plus chemotherapy extended mPFS by nearly 9 months in EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial September 13, 2023
REZILIENT3 Global First-Line Trial of Zipalertinib Launched in Patients With NSCLC Harboring EGFR Exon 20 Insertion Mutations August 9, 2023
Treatment with RYBREVANT® (amivantamab-vmjw) + Chemo Resulted in Statistically Significant PFS Improvement in Patients with 1L EGFR Ex 20 Ins Mutation-Positive NSCLC July 27, 2023
FDA clears FDA INDA for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer July 19, 2023
C4 Therapeutics and Betta Pharmaceuticals Announce Exclusive Licensing Agreement for the Development and Commercialization in Greater China of CFT8919 June 6, 2023