Gavreto

After Scotland says no, NICE backs Lilly’s Retsevmo for lung cancer

Eli Lilly’s RET inhibitor Retsevmo can now be prescribed on the NHS for people with RET fusion-positive advanced non-small cell lung cancer (NSCLC) in England and Wales, within the Cancer Drugs Fund (CDF). The recommendation from health technology assessment (HTA) agency NICE comes a couple of weeks after Retsevmo (selpercatinib) was cleared for use in …

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Roche, Blueprint’s RET cancer drug Gavreto cleared in EU

Roche and Blueprint Medicines have opened a second front in their rivalry with Eli Lilly in RET-mutated cancers, after getting approval for Gavreto from the European Commission. Gavreto (pralsetinib) has been cleared as a first-line treatment of people with RET fusion-positive advanced non-small cell lung cancer (NSCLC), a disease that is diagnosed in around 37,000 …

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Roche’s Gavreto (pralsetinib) Receives the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers

Shots: The approval is based on P-I/II ARROW study involve assessing Gavreto (400mg, qd) n people with rearranged during transfection (RET) fusion-positive NSCLC, RET-mutant MTC, RET fusion-positive thyroid cancer, and other RET-altered solid tumors The study demonstrated durable clinical activity in people with/out prior therapy and regardless of RET alteration genotypes Gavreto is a once-daily, …

Roche’s Gavreto (pralsetinib) Receives the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers Read More »

Roche, Blueprint raise pressure on Lilly with new Gavreto approval

The FDA has cleared Roche and Blueprint Medicine’s Gavreto for a new use in RET-mutated thyroid cancer, putting it on a level playing field with Eli Lilly’s rival therapy Retevmo. The US regulator says Gavreto (pralsetinib) can be used to treat patient aged over 12 with advanced or metastatic RET-mutant thyroid tumours, adding to its …

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Catalent Signs Commercial Supply Agreement with Blueprint Medicines Following FDA Approval of GAVRETO™ (pralsetinib)

Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it had entered into a commercial supply agreement with Blueprint Medicines following FDA approval of GAVRETO™ (pralsetinib). Developed by Blueprint Medicines, GAVRETO is a new therapy indicated for …

Catalent Signs Commercial Supply Agreement with Blueprint Medicines Following FDA Approval of GAVRETO™ (pralsetinib) Read More »

Insights+: The US FDA New Drug Approvals in September 2020

The US FDA has approved 6 NDAs in Sept 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 85 novel products so far in 2020, including 6 in Sept 2020. Additionally, last year …

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