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Novartis: FDA approves Tafinlar + Mekinist in lung cancer.

(CercleFinance.com) - Novartis said on Friday that US regulators have approved Tafinlar, in combination with Mekinist, to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600E mutation.


The US Food and Drug Administration (FDA) granted the combination a breakthrough therapy designation in July 2015 for the treatment of patients with this kind of cancer who received previous treatment with chemotherapy.

Today Novartis also disclosed results from two clinical trials, which found that approximately half of adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP) who discontinued Tasigna remained in treatment-free remission (TFR) nearly two years after stopping treatment.

Finally, the Swiss biopharmaceutical firm Novartis announced updated results from a clinical trial, demonstrating CTL019 (tisagenlecleucel) remission rates are maintained at six months in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).

These data show that 83% of patients achieved complete remission (CR) or CR with incomplete blood count recovery within three months of infusion.


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