Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

 Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Shots:

  • The BLA is based on the P-I CHRYSALIS study assessing amivantamab as a monothx. and in combination with lazertinib in adult patients with advanced NSCLC
  • The company has established an EAP for patients in the US who may be eligible to obtain access to mivantamab during the review of the BLA
  • Amivantamab is an EGFR & MET bispecific Ab with the immune cell-directing activity that targets tumors with activating & resistance to EGFR & MET mutations & amplifications. Amivantamab has received the US FDA’s BTD in Mar’2020

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Wypages

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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