AbbVie’s leukaemia drug granted positive opinion by MHRA through EAMS
pharmafile | August 23, 2016 | News story | Research and Development, Sales and Marketing |
AbbVie’s investigational treatment for chronic lymphocytic leukaemia (CLL) venetoclax has been granted a positive scientific opinion by the Medicines and Healthcare products Regulatory Agency (MHRA) through the Early Access to Medicines Scheme (EAMS).
The drug is the first of its kind to be made available through the scheme. The EAMS aims to make promising innovative medicines available to those patients in the UK who have a high unmet clinical need, and has only been granted to four products since its inception in 2014. This decision means that CLL sufferers could potentially be given access to the treatment while regulatory bodies review its Marketing Authorisation Application.
Venetoclax’s mode of action works by targeting the B‐cell lymphoma‐2 (BCL-2) protein, which regulates cell survival, restoring the body’s ability to trigger cancer cell self-destruction (apoptosis).1,6 The treatment represents an important potential option for difficult-to-treat CLL patients who have certain genetic mutations, or those who have failed BCRi treatments, and who have previously had limited treatment options.
“As part of AbbVie’s fight against CLL we are delighted to receive the EAMS positive scientific opinion which will help ensure that eligible patients with limited current treatment options gain access to this therapy as soon as possible,” says Alice Butler, medical director at AbbVie UK. “AbbVie is proud to have entered into the voluntary EAMS and today’s positive announcement marks another important step for patients with CLL.”
There are over 3,000 cases of CLL each year in the UK, with the average age of diagnosis being 71. Through the EAMS, venetoclax is indicated for the treatment of adult patients with CLL in the presence of 17p deletion or TP53 mutation, and who are unsuitable for or have failed a B-cell receptor pathway inhibitor (BCRi). In addition, venetoclax can be used in the treatment of adult patients with CLL in the absence of 17p deletion or TP53 mutation, and who are unsuitable for or have failed both chemo-immunotherapy and a BCRi.
Matt Fellows
