EMEA approves new starting dose for SPRYCEL in chronic myeloid leukaemia
For patients with advanced (accelerated or blast) phase CML resistant or intolerant to prior therapy including imatinib or Philadelphia chromosome positive acute lymphoblastic leukaemia resistant or intolerant to prior therapy, the starting dose remains 70 mg BID.
Welcoming the news, Professor Jane Apperley, Chief of Service for Clinical Haematology at the Hammersmith Hospital, London and Chair of the Department of Haematology, said, "The introduction of the new 100 mg once-daily dose is good news for chronic phase CML patients starting on Sprycel who are resistant or intolerant to imatinib. Results have shown that a reduced starting dose to 100 mg is just as efficacious as the 140 mg starting dose with an even greater benefit of improved tolerability. The once-a-day dosing regimen is also simple and convenient for patients because with Sprycel there are no fasting requirements nor do patients need to take it with food. This advance in the treatment of chronic phase CML [resistant or intolerant to imatinib] will benefit many patients who previously had very limited treatment choices and provides clinicians with further options in managing this devastating disease."
The new 100mg starting dose reflected in the label change is based upon an ongoing Phase III (034), open-label, randomised, multi-centre international trial from 139 clinical trial sites that was conducted to determine the most effective starting dose regimen of Sprycel in patients with chronic phase CML who were resistant or intolerant to imatinib.
"Bristol-Myers Squibb is pleased about the approval of the 100 mg once-daily starting dose of Sprycel for chronic phase patients resistant or intolerant to imatinib. The clinical data on the new starting dose demonstrate improved patient tolerability whilst maintaining efficacy compared to the previous starting dose of 70 mg twice daily," said Frank Pasqualone, General Manager, Bristol-Myers Squibb UK. He added, "This continues to confirm our dedication to patients by finding the optimal use for our medicines, continuing to invest in them even after our licence is granted."
The new 100mg daily starting dose for patients resistant or intolerant to imatinib offers:
- Response rates comparable to the 70mg twice daily dose
- Improvement in the incidence and the severity of adverse events compared to the 70mg twice daily dose
- Simple and convenient dosing making it easier for patients to take their treatment
- Sprycel does not need to be taken with food
- There are no fasting requirements before or after taking Sprycel
- Sprycel can be taken consistently either in the morning or at night
Specific improvements in the benefit - risk assessment compared to the 70 mg twice daily dose include:
- A reduced incidence of fluid retention
- Pleural effusion (an accumulation of fluid between the two membranes surrounding the lung that may lead to shortness of breath, cough, rapid breathing and chest pain) was less frequently reported
- Grade 3/4 pleural effusion occurred in only 1% of patients
- A reduced incidence of myelosuppression1m (a reduction in blood-cell production by the bone marrow)
CML is a devastating condition which accounts for around 15% of all leukaemias.2 Around 2,600 people in the UK are currently affected by CML3 with approximately 600 new cases reported each year.4 The majority of CML cases - 85% - are diagnosed in the chronic phase.5 Evidence indicates that resistance to imatinib occurs in approximately 29% of patients with chronic phase CML.6
The SPC label change
The new label change only affects chronic phase CML patients. The new recommended starting dose for chronic phase CML patients resistant or intolerant to imatinib is 100 mg once-daily. The recommended starting dose for advanced phase (blast or accelerated phase) CML patients remains 70 mg twice-daily.
About SPRYCEL®
Sprycel is the first effective therapy option indicated for adults with chronic, accelerated or blast phase chronic myeloid leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate.
It is also indicated for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.1o
Sprycel has been shown to have a manageable side effect profile7 with the most common non-haematological side effects being gastrointestinal (diarrhoea, nausea and vomiting), fluid retention events (peripheral oedema and pleural effusion), headache and fatigue.
Sprycel received EMEA approval and was launched in November 2006.
About BMS
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life.
References:
1. SPRYCEL® Summary of Product Characteristics (revised August 2007)
2. National Comprehensive Cancer Network (NCCN).Chronic Myelogenous Leukemia - clinical practice guidelines in oncology - v1 2007.
3. NICE Guidance on the use of imatinib for chronic myeloid leukaemia - Technology Appraisal 70. October 2003.
4.Cancer Research UK 2006. CML incidence UK. Available at:http://www.cancerhelp.org.uk/help/default.asp?page=4836. Accessed 01/11/06.
5. Faderl S. NEJM 1999; 341: 3: 164-172
6. Lahaye T, et al. Cancer 2005; 103:1659-69
7. FDA labelling information - online http://www.fda.gov/cder/foi/label/2006/021986lbl.pdf. Accessed on 01/11/06.
http://www.emea.europa.eu/
View drug information on Sprycel.
EMEA a aprobat noi incepand dozã de SPRYCEL în cronice myeloid leucemie - EMEA approves new starting dose for SPRYCEL in chronic myeloid leukaemia - articole medicale engleza - startsanatate