Linkedin
RLS logo_header
Linkedin

FDA issues CRL for BLA for fixed combination of amivantamab and human hyaluronidase for SC amivantamab in patients with NSCLC with EGFR mutations

“We’re working closely with the FDA to bring SC amivantamab to patients as quickly as possible, and are confident in our path to resolution,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D. Global Therapeutic Area Head, Oncology, Innovative Medicine, Johnson & Johnson. “Backed by interim overall survival data showing a strong favorable trend compared to osimertinib, we believe strongly in the robust efficacy and safety of RYBREVANT – both as a standalone treatment and in combination with LAZCLUZE – for EGFR-mutated advanced lung cancer. We’re proud to have helped so many patients in the front-line setting already with RYBREVANT and look forward to further expanding treatment options with our subcutaneous formulation pending regulatory review and approval.”

Read the full story on "FDA issues CRL for BLA for fixed combination of amivantamab and human hyaluronidase for SC amivantamab in patients with NSCLC with EGFR mutations"

Share:

More News

FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient

Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase

Development of EO-3021 to be Discontinued

“We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to

FDA Orphan Drug Designation for HLX22/AC101 in Gastric Cancer

Søren Bregenholt, CEO of Alligator, commented: “The FDA’s recognition of HLX22/AC101’s potential with Orphan Drug Designation is a notable recognition. While Alligator’s is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator.”

Servier and Black Diamond Therapeutics Announce Global Licensing Agreement for BDTX-4933

“At Servier, we are dedicated to transforming patient care in areas with significant unmet needs. Our partnership to develop BDTX-4933 is an important opportunity in targeted cancer therapies, as we believe we can serve more people by helping the right patients find the right treatment, at the right time,” said

Onco-This-Week

About Us

Sign up for OTW

Linkedin

Disclaimer: The OTW team takes care to share authentic information. In case of any discrepancies please write to newsletter@onco-this-week.com. Our website is an aggregator for open-source oncology news. The information on our website is provided without any representations or warranties. OTW is part of RLS Consultants, a global consulting and training firm focusing exclusively on the healthcare and life sciences industries. RLS is a leading provider of opportunity assessment services, utilizing its comprehensive expertise in strategic market research, forecasting, and modeling, as well as pricing and market access to facilitate commercial assessments. RLS does not have any influence on any news reported on OTW. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of RLS. The content on our website is intended strictly for news and information purposes only and should not be treated as a substitute for medical advice, diagnosis, or treatment. News shared on OTW should not be utilized in real-world analytic products as they are based only on limited and dated open-source information.