Approval is based on data from the Phase III CodeBreaK 300 trial, which demonstrated that treatment with Lumakras and ...
The FDA approves Amgen's Lumakras in combination with Vectibix for treating previously treated adults with KRAS G12C-mutated metastatic colorectal cancer.
Amgen receives US FDA approval for Lumakras in combo with Vectibix for chemorefractory KRAS G12C-mutated metastatic colorectal cancer: Thousand Oaks, California Monday, January 20 ...
In the CodeBreaK 300 trial, sotorasib and panitumumab had better response rates and improved PFS vs standard-of-care ...
The US regulator has cleared Lumakras (sotorasib) in combination with Amgen's anti-EGFR antibody Vectibix (panitumumab) for ...
The FDA also approved Qiagen's Therascreen KRAS RGQ PCR kit as a companion diagnostic to identify KRAS G12C-mutant patients.
The FDA approved two oncology regimens on Jan. 16.One is for a subset of patients with colorectal cancer and the other for ...
The Food and Drug Administration approved Amgen Inc ‘s AMGN Lumakras (sotorasib) in combination with Vectibix (panitumumab) ...
Friday announced that the U.S. Food and Drug Administration has approved its Lumakras plus Vectibix combination ...
THOUSAND OAKS, Calif. - Amgen (NASDAQ:AMGN), a prominent biotechnology company with a market capitalization of $144.8 billion, has received FDA approval for LUMAKRAS® (sotorasib) in combination with ...
Pivotal Study Demonstrated the Combination More Than Doubled Progression-Free Survival Compared to Investigated SOC THOUSAND OAKS, Calif., Jan. 17, 2025 /PRNewswire/ ...
Approval was based on the pivotal Phase 3 CodeBreaK 300 study.