Novartis Scemblix® FDA approved in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile [Yahoo! Finance]
Novartis AG (NVS)
Last novartis ag earnings: 4/28 01:00 am
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Source: Yahoo! Finance
favorable safety and tolerability profile in a Phase III trial vs. all standard of care (SoC) therapies Patients on Scemblix also had fewer dose reductions and half the rate of adverse reactions leading to treatment discontinuation Nearly 50% of CML patients do not meet efficacy milestones (MMR) with current SoC and almost 25% discontinue or switch therapies within one year of treatments Scemblix now approved for newly diagnosed and previously treated CML, allowing four times the patients access to potential new standard of care Basel, October 29, 2024 – Novartis announced today that Scemblix ® (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). The accelerated approval is based on major molecular response rate (MMR) at week 48 from the ASC4FIRST Phase III trial that compared once daily Scemblix to all other in
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NVS
Earnings
- 10/29/24 - Beat
NVS
Sec Filings
- 10/29/24 - Form 6-K
- 10/29/24 - Form 6-K
- 9/18/24 - Form 6-K
- NVS's page on the SEC website