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Switching between liquid and tablet/capsule formulations - Which medicines require extra care?

19 July 2021For a small number of medicines, there are differences in equivalent doses of oral formulations of the same medicine. This needs to be considered when…

Safety in Lactation: Protein kinase inhibitors

23 September 2020Protein kinase inhibitors, whether used as monotherapy or in combination with other antineoplastics, are contra-indicated in breastfeeding because of their effects on dividing cells and…
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Lactation Safety Information

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

New Medicines

SprycelPhiladelphia-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
Oct 20Oral suspension formulation launched in the UK. It is licensed for treatment of paediatric patients with newly diagnosed Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib, and for newly diagnosed Ph+ ALL in combination with chemotherapy. 10mg/ml powder for oral susp, 990mg=£626.74. One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate). After constitution, one bottle contains 99 mL of oral suspension. Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate) [10,11].
Feb 19Approved in EU for use in combination with chemotherapy for treatment of paediatric patients with newly diagnosed Ph+ ALL [9].
Jan 19Approved 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 18Recommended for EU approval by CHMP - the additional indication is "treatment of paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy.” [7].
Aug 18Filed 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 05Granted 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

Jul 21NICE TA Terminated Bristol Myers Squibb did not provide an evidence submission [12].
Aug 18Primary data for NCT01460160 collected May 2017. Study active but not recruiting [5].
Dec 16Primary data for NCT01460160 due May 2017 [4]
Jan 12PII (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