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FDA Nod For Loxo/Bayer Tissue Agnostic Drug Marks Paradigm Shift In Cancer

 
• By Kevin Grogan

Vitrakvi is effective against a wide variety of cancers driven by NTRK fusion. But finding the patients who will benefit will be a challenge, given there are expected to be only around 2,500 to 3,000 new cases in the US and testing for the mutation is uncommon. 

Scientist
FDA Presses Green Light For Vitrakvi • Source: Shutterstock

In a momentous move for precision medicine, the FDA has granted accelerated approval to Loxo Oncology Inc. and Bayer AG's cancer treatment Vitrakvi (larotrectinib) based on a common biomarker rather than the location in the body where the tumor originated.

Vitrakvi has got the thumbs-up for the treatment of both adult and children with solid tumors that have a neurotrophic...

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Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.

Schrödinger Drops CDC7 Inhibitor SGR-2921 After Two Patient Deaths

 
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• By Mary Jo Laffler

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AstraZeneca Launches At-Home Flu Vaccine Amid Industry DTC Push

 
• By Alaric DeArment

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Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.

Schrödinger Drops CDC7 Inhibitor SGR-2921 After Two Patient Deaths

 
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