Delivering on the promise of precision medicine, Loxo Oncology Inc.'s larotrectinib could be the first of a modern form of oncology drug development – facilitated by US FDA's breakthrough designation program.
Loxo Sees Larotrectinib As Model Form Of Oncology Drug Development
The pivotal data presented at ASCO showed a 76% response rate for the TRK inhibitor in patients with TRK fusion abnormalities, but there's still a lot left to prove about the tissue-agnostic model of drug development.
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The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
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