logo
Plus   Neg
Share
Email

Novartis Drug Rydapt Gets EU Approval For Newly Diagnosed FLT3-mutated AML

Novartis said that the European Commission approved Rydapt (midostaurin) for two indications in rare, hard-to-treat cancers.

Rydapt is approved for use in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive.

It was also cleared for use as monotherapy for the treatment of adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia.

The approval follows a positive opinion issued by the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on July
20, 2017 and applies to all 28 EU member states, plus Iceland, Liechtenstein and
Norway.

For newly diagnosed FLT3-mutated AML, the approval is based on data from the RATIFY (CALGB 10603 [Alliance]) trial, which was conducted in collaboration with the Alliance for Clinical Trials in Oncology and 13 international cooperative groups.

The study showed a 23% reduction in the risk of death with Rydapt plus standard chemotherapy compared with placebo plus standard chemotherapy. Median overall survival of 74.7 months and 25.6 months, respectively (hazard ratio [HR] = 0.77, 95% confidence interval [CI], 0.63, 0.95; one-sided p=0.0078).

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Alphabet's subsidiary Loon LLC has secured its first commercial deal - to deliver 4G internet access to remote areas of Kenya using high-altitude balloons. Loon will partner with Telkom Kenya to deliver connectivity to parts of Kenya. Telkom Kenya announced Thursday that it has signed a definitive agreement with Loon to pilot a new 4G/LTE access network service in Kenya. The Cow Calendar era is coming to an end. Chick-fil-A said it is axing one of its well-loved products, the Cow Calendar. The 2018 Cow Calendar will be the chicken chain's last calendar. Chick-fil-A first launched the Cow Calendar in 1998 that featured cows as a new tool to convince people to eat more chicken. The calendars were popular not just for the pictures of funny Chick-fil-A cows. Japanese telecom giant Nippon Telegraph and Telephone or NTT has filed a patent for a blockchain technology-based new contract agreement method. NTT, the world's fourth-largest telecom provider, explains the ways to use the application to store contracts without tampering documents.
Follow RTT