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

RTTNews | vor 597 Tagen
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.

read more
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 | vor 441 Tagen
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 | vor 1087 Tagen
Swiss Market Ends Modestly Higher After Mild Struggle

Swiss Market Ends Modestly Higher After Mild Struggle

The Switzerland market recovered after a flat start on Thursday, and after staying positive till well past noon, suffered a setback but regained some strength to eventually end the day's session modestly higher.
RTTNews | vor 1Std 53 Minuten
Major European Markets Close On Positive Note

Major European Markets Close On Positive Note

Amid expectations of a rate cut from the Federal Reserve in September, and hopes the meeting between the Presidents of the U.S. and Russia will help end the war in Ukraine, the major European markets closed on a positive note on Thursday, although the U.K. market underperformed other major markets in the region.
RTTNews | vor 2Std 9 Minuten
U.S. Producer Price Growth Far Exceeds Estimates In July

U.S. Producer Price Growth Far Exceeds Estimates In July

Producer prices in the U.S. increased by much more than expected in the month of July, the Labor Department revealed in a report released on Thursday. The Labor Department said its producer price index for final demand shot up by 0.9 percent in July after coming in unchanged in June. Economists had expected producer prices to rise by 0.2 percent.
RTTNews | vor 4Std 37 Minuten