Date: 2017-11-09
Type of information: Granting of a Market Authorisation in the US
Product name: Sprycel®
Compound: dasatinib
Therapeutic area: Cancer - Oncology
Action mechanism:
- tyrosine kinase inhibitor. Dasatinib is an oral dual BCR/ABL and Src family tyrosine kinase inhibitor approved for use in patients with chronic myelogenous leukemia. The main targets of dasatinib, are BCRABL, SRC, Ephrins and GFR.
- Sprycel first received U.S. Food and Drug Administration (FDA) approval in 2006 for the treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) who are resistant or intolerant to prior therapy including imatinib. At that time, Sprycel also received FDA approval for adults with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to prior therapy. Sprycel is approved for these indications in more than 60 countries.
In October 2010, Sprycel received accelerated FDA approval for the treatment of adults with newly diagnosed Ph+ CML in chronic phase. This indication is approved in more than 50 countries.
Company: BMS (USA - NY)
Disease:
- pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)
Latest news:
- • On November 9, 2017, the FDA granted regular approval to dasatinib (Sprycel®, Bristol-Myers Squibb Co.) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. Approval was based on data from 97 pediatric patients with chronic phase CML evaluated in two trials—a phase 1, open-label, non-randomized, dose-ranging trial and a phase 2, open-label, non-randomized trial. Fifty-one patients exclusively from the phase 2 trial were newly diagnosed with chronic phase CML and 46 patients (17 from the phase 1 trial and 29 from the phase 2 trial) were resistant or intolerant to previous treatment with imatinib. The majority of patients were treated with dasatinib tablets 60 mg/m2 once daily. Patients were treated until disease progression or unacceptable toxicity.
- After 24 months of treatment, 96.1% of newly diagnosed patients (95% CI: 86.5, 99.5) and 82.6% of patients resistant or intolerant to imatinib (95% CI: 68.6, 92.2) had complete cytogenic response (CCyR). With a median follow-up of 4.5 years in newly diagnosed patients and 5.2 years in imatinib-resistant or -intolerant patients, the median durations of CCyR, major cytogenic response (MCyR), and major molecular response (MMR) could not be estimated as more than half of the responding patients had not progressed at the time of data cut-off.
- Adverse reactions reported in 10% of dasatinib-treated pediatric patients (n=97) were headache, nausea, diarrhea, skin rash, vomiting, pain in extremity, abdominal pain, fatigue, and arthralgia. The recommended dose of dasatinib in pediatric patients is based on body weight.
- FDA granted priority review and orphan product designation to dasatinib for this indication.
- • On July 10, 2017, BMS announced that the FDA accepted its supplemental New Drug Application (sNDA) to include an indication for Sprycel® (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase (CP) chronic myeloid leukemia (CML), as well as a powder for oral suspension (PFOS) formulation of Sprycel. The application is under priority review with an action date of November 9, 2017. The sNDA includes data from CA180-226 (NCT00777036), an ongoing Phase 2, open-label, non-randomized trial studying Sprycel in pediatric patients with CP-CML that are resistant to or intolerant of imatinib and in pediatric patients newly diagnosed with CP-CML. The efficacy endpoints included cumulative major cytogenetic response rate among imatinib-resistant or intolerant patients and cumulative complete cytogenetic response rate in newly diagnosed patients. Additional efficacy measures were time to and duration of response, progression-free survival, overall survival and major molecular response. Safety was also assessed.
- Data from this study were shared in oral presentations at the American Society of Clinical Oncology Annual Meeting 2017 in Chicago on June 5 and the 22nd Congress of the European Hematology Association on June 24.
- • On May 19, 2017, BMS announced that the European Medicines Agency (EMA) validated its grouped Type II variation/Extension of Application for Sprycel® (dasatinib) to treat children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) and to include the powder for oral suspension. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. The application includes data from CA180-226 (NCT00777036), an ongoing Phase 2, open-label, non-randomized trial studying Sprycel in newly diagnosed chronic phase CML pediatric patients and in pediatric patients resistant to or intolerant of imatinib.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-11-09
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
