Dasatinib

Articles · Lactation Safety Information · New Medicines ·
422756008

Articles

Lactation Safety Information

Only anecdotal evidence of safety which indicates no effects in one breastfed infant
Serious adverse effects reported in adults
9th January 2017

New Medicines

Sprycel · Philadelphia-positive chronic myelogenous leukaemia (CML) in children - tablet and oral suspension formulations

Information

Sprycel
Licence extension / variation and new formulation
Bristol-Myers Squibb
Bristol-Myers Squibb

Development and Regulatory status

Launched
Launched
Pre-registration (Filed)
July 2018
Jul 18 · Approved in EU for ´treatment of children and adolescents aged 1 - years with Philadelphia positive CP-CML in chronic phase´. A powder for oral suspension formulation is also approved [6].
Apr 18 · Recommended for approval by CHMP: the additional indication is "for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML‑CP) or Ph+ CML‑CP resistant or intolerant to prior therapy including imatinib" [5].
Jul 17 · Supplementary NDA accepted for priority review by FDA with target action date of 9/11/17. Application includes data from from CA180-226 (NCT00777036) [3].
May 17 · EMA have validated a type II variation application for dasatinib to treat children (aged 1 - 18 years) with Philadelphia positive CP-CML, and for dasatinib powder for oral suspension. Validation of the application begins the EMA’s centralized review process [4].

Category

Small molecule tyrosine kinase inhibitor that inhibits the overproduction of leukaemia cells in the bone marrow. It inhibits Bcr/Abl, c-KIT, PDGFR, EphA2 and Src.
Annual incidence of CML is between 1 and 2 cases per 100,000. Presentation can occur at any age; however, it is rare in children (CML represents only 5% of childhood leukaemia) [2].
Philadelphia-positive chronic myelogenous leukaemia (CML) in children - tablet and oral suspension formulations
Oral

Further information

Yes
To be confirmed

Trial or other data

Jul 17 · PII (NCT00777036) study to determine whether treatment with dasatinib is effective and safe in children and adolescents with newly diagnosed chronic phase CML (CP-CML) or with philadelphia positive leukemias resistant or intolerant to imatinib is ongoing. 139 children will be recruited from sites worldwide including US & EU (including UK) [1].
Jun 17 · BMS release initial results from NCT00777036. Patients with CP-CML resistant to or intolerant of imatinib who received dasatinib demonstrated a MCyR rate of 55.2% [95% CI 36 to 74]) 3 months into treatment, increasing to >90% [73 to 98) at 24 months. Newly diagnosed patients with CP-CML, achieved a CCyR rate of 64% [53 to 74] as early as 6 months into treatment; increasing to 94% (87 to 98) at 24 months [4].
Jun 17 · Primary endpoint in NCT00777036 is cumulative major cytogenetic response (MCyR) rate for patients with CP-CML resistant to or intolerant of imatinib (threshold of clinical interest >30%). Primary endpoint for newly diagnosed patients with CP-CML is cumulative complete cytogenetic response (CCyR) rate (threshold of clinical interest >55%) [1].

Evidence based evaluations

Sprycel · Philadelphia-positive acute lymphoblastic leukaemia (ALL) in children - tablet and oral suspension formulation

Information

Sprycel
Licence extension / variation and new formulation
Bristol-Myers Squibb
Bristol-Myers Squibb

Development and Regulatory status

Launched
Launched
Launched
February 2019
Yes
Feb 19 · Approved in EU for use in combination with chemotherapy for treatment of paediatric patients with newly diagnosed Ph+ ALL [9].
Jan 19 · Approved by US FDA for treatment of children aged ≥1 year with newly diagnosed disease. The approval is based on data from the phase II study, CA180-372 [8].
Dec 18 · Recommended for EU approval by CHMP - the additional indication is "treatment of paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy.” [7].
Aug 18 · Filed in US for treatment of paediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). Application is based on data from ongoing PII trial CA180-372 [6].
Dec 05 · Granted orphan designation (EU/3/05/338) by the European Commission for treatment of ALL [3].

Category

Small molecule tyrosine kinase inhibitor that inhibits the overproduction of leukaemia cells in the bone marrow. It inhibits Bcr/Abl, c-KIT, PDGFR, EphA2 and Src.
Acute leukaemia is an uncommon form of haematological malignancy. About 7,600 people are diagnosed with leukaemia each year in the UK. Of these, only about 650 people have ALL [1].
Philadelphia-positive acute lymphoblastic leukaemia (ALL) in children - tablet and oral suspension formulation
Oral

Trial or other data

Aug 18 · Primary data for NCT01460160 collected May 2017. Study active but not recruiting [5].
Dec 16 · Primary data for NCT01460160 due May 2017 [4]
Jan 12 · PII (NCT01460160) study to determine whether dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive ALL starts. 75 children will be recruited from sites worldwide including US & EU (Including UK)> the study is expected to complete collection of primary outcome data (event-free survival rate) in May 17 [2].

Evidence based evaluations