Amgen Says FDA Completes Review Of SNDA Seeking Full Approval For LUMAKRAS

RTTNews | 485 dias atrás
Stocktwits
Amgen Says FDA Completes Review Of SNDA Seeking Full Approval For LUMAKRAS

(RTTNews) - Amgen, Inc. (AMGN) announced Tuesday that the U.S. Food and Drug Administration (FDA) has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS (sotorasib).

The review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).

The FDA also issued a new postmarketing requirement (PMR) for an additional confirmatory study to support full approval that will be completed no later than February 2028.

In addition, the FDA concluded that the dose comparison PMR issued at the time of LUMAKRAS accelerated approval, to compare the safety and efficacy of LUMAKRAS 960 mg daily dose versus a lower daily dose, has been fulfilled.

The company said LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated NSCLC under accelerated approval.

Marcadores : AMGN
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Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

The U.S. Food and Drug Administration has approved Amgen Inc.'s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab), developed by British drug major AstraZeneca's Rare Disease unit Alexion Pharmaceuticals, to treat certain rare diseases. Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria or PNH...
RTTNews | 329 dias atrás
Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959

Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959

Amgen, Inc. (AMGN) announced Tuesday positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
RTTNews | 975 dias atrás
Thai Stock Market Tipped To Open To The Upside On Friday

Thai Stock Market Tipped To Open To The Upside On Friday

The Thai stock market on Thursday snapped the two-day winning streak in which it had gained almost 20 points or 1.8 percent. The Stock Exchange of Thailand now sits just above the 1,145-point plateau although it's expected to rebound on Friday.
RTTNews | 28 minutos atrás
Indonesia Shares May Bounce Higher Again On Friday

Indonesia Shares May Bounce Higher Again On Friday

The Indonesia stock market on Thursday wrote a finish to the four-day winning streak in which it had climbed almost 240 points or 3.7 percent. The Jakarta Composite Index now rests just above the 6,610-point plateau although it's expected to see renewed support on Friday.
RTTNews | 59 minutos atrás
Renewed Support Predicted For Hong Kong Shares

Renewed Support Predicted For Hong Kong Shares

The Hong Kong stock market on Thursday snapped the three-day winning streak in which it had jumped more than 1,000 points or 4.5 percent. The Hang Seng Index now sits just above the 21,900-point plateau although it's got a solid lead again for Friday's trade.
RTTNews | 1h 13min atrás
Higher Open Called For China Stock Market

Higher Open Called For China Stock Market

The China stock market ticked higher again on Thursday, one day after ending the two-day winning streak in which it had risen almost 25 points or 0.8 percent. The Shanghai Composite Index now sits just beneath the 3,300-point plateau and it may see additional support on Friday.
RTTNews | 1h 29min atrás
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