FDA Approves LUMAKRAS™ (Sotorasib), The First And Only ... - Amgen
2021年5月28日 · The CodeBreaK clinical development program for Amgen's drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.
新突破：全球首款KRAS抑制剂获批上市，“不可成药”靶点新生！
2021年7月23日 · 2021年5月29日，美国FDA宣布，加速批准安进（Amgen）公司开发的Lumakras（sotorasib，AMG510）上市，用于治疗肿瘤携带KRAS G12C突变的非小细胞肺癌（NSCLC）患者，这些患者至少接受过一种前期全身性治疗。
首款KRAS抑制剂“转正”遇挫 业内感叹新药生意越来越难
《科创板日报》10月8日讯（记者 徐红） 日前，美国FDA举行了ODAC会议，讨论首款获批的KRAS抑制剂、由安进（Amgen）公司开发的Lumakras（通用名：sotorasib）是否可以从加速批准转为完全批准（full approval），即业界俗称的“转正”。 但令人惋惜的是，这款明星产品并未通过此次ODAC大考。 会议最后， 专家组以2票赞同，10票反对的结果，认为sotorasib的III期验证临床CodeBreaK 200的无进展生存期（PFS）结果无法被可靠地解释。 在一般情况下，ODAC会 …
FDA APPROVES LUMAKRAS® (SOTORASIB) IN COMBINATION …
THOUSAND OAKS, Calif., Jan. 17, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS ® (sotorasib) in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA ...
KRAS Information Center | Amgen
Follow Amgen Oncology on and for the latest updates and learn more about Amgen's commitment to the relentless pursuit of breakthroughs for cancer patients with NSCLC and other solid tumors with KRAS G12C mutations at .
FDA approves sotorasib with panitumumab for KRAS G12C …
On January 16, 2025, the Food and Drug Administration approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for adult patients with KRAS G12C-mutated metastatic...
BMS touts KRAS confirmatory trial win after Amgen's stumble
2024年3月29日 · Bristol Myers Squibb looks on track to overtake Amgen as the KRAS leader in lung cancer after following up its rival’s FDA setback with a positive confirmatory trial readout.
Targeting KRAS-G12C | Amgen Oncology
Learn about the role of KRAS mutations in cancer cell growth and survival, and how Amgen is targeting mutant KRAS G12C.
The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour ... - PubMed
In immune-competent mice, treatment with AMG 510 resulted in a pro-inflammatory tumour microenvironment and produced durable cures alone as well as in combination with immune-checkpoint inhibitors. Cured mice rejected the growth of isogenic KRAS G12D tumours, which suggests adaptive immunity against shared antigens. Furthermore, in clinical ...
Oncologists greet Lumakras: the world’s first KRAS inhibitor
2021年9月9日 · Fewer than three years after starting clinical testing, Amgen’s drug Lumakras (sotorasib) received US Food and Drug Administration (FDA) approval for non-small-cell lung cancers that harbor...