Japan Approves Amgen’s LUMAKRAS

Amgen (NASDAQ: AMGN), an American multinational biopharmaceutical company, announced that Japan has approved LUMAKRAS (sotorasib), the first-of-its-kind KRAS G12C inhibitor.

It is designed to treat KRAS G12C-mutated positive, unresectable, advanced, and/or recurrent non-small cell lung cancer (NSCLC) that has progressed post systemic anticancer therapy. 

Notably, in March 2021, LUMAKRAS was granted Orphan Drug Designation by the Japan Ministry of Health, Labour, and Welfare (MHLW). 

Supporting Data 

Amgen said that the regulator’s approval followed positive data from the Phase 2 CodeBreaK 100 clinical trial in NSCLC. LUMAKRAS 960 mg, which was administered orally once-daily, showed an objective response rate (ORR) of 37% in 123 participants. 

Lung cancer is the second most common cancer worldwide, with the total number of patients estimated to be around 169,000 in Japan. 

Official Comments 

EVP of Research and Development at Amgen, David M. Reese, said, “Today’s approval of LUMAKRAS as the first and only KRASG12C inhibitor marks a paradigm shift in the treatment of patients with non-small cell lung cancer in Japan.” 

“In just over three years since the first patient was dosed in the pivotal CodeBreaK 100 trial, LUMAKRAS is now approved in nearly 40 countries, illustrating our commitment to accelerating transformative medicines for patients living with cancers that have yet to be fully addressed,” Reese added. 

Wall Street’s Take 

Overall, the stock has a Hold consensus rating based on 3 Buys, 9 Holds, and 1 Sell. The average Amgen price target stands at $231.92 and implies upside potential of 1.32% to current levels. Shares have lost 6.9% over the past year. 

Hedge Fund Trading Activity 

According to TipRanks’ data, Wall Street’s top hedge funds have decreased holdings in the stock by 359.3 thousand shares in the last quarter, indicating a negative hedge fund confidence signal in the Amgen stock based on activities of 17 hedge funds in the recent quarter.

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