EMA approvals for rival blood cancer drugs
pharmafile | July 27, 2014 | News story | Research and Development, Sales and Marketing | CLL, Gilead, Janssen, chronic lymphocytic leukaemia, imbruvica, zydelig
Gilead and Janssen are set to face off in Europe after the CHMP recommended both of their rival blood cancer drugs be approved on the continent.
Janssen’s Imbruvica (ibrutinib) and Gilead’s Zydelig (idelalisib) have been recommended for chronic lymphocytic leukaemia (CLL) patients who have received at least one prior treatment, as well as a first-line treatment for patients with a specific genetic mutation that makes them unsuitable for chemo-immunotherapy.
The final decision as to whether they will enter onto the EU market is to be made by the European Commission; typically this takes around three months.
Imbruvica, which gained US approval in November last year, is also recommended for use in the treatment of patients with mantle cell lymphoma that has come back after previous treatments, or is not responding to other treatments.
Analysts surveyed by Bloomberg expect Janssen’s treatment to be making around $3.3 billion by 2018.
Gilead’s drug also has a secondary indication as it can be used for patients with follicular lymphoma that has not responded to two previous treatments.
Some analysts have estimated that Zydelig could eventually reach annual sales between $1 billion and $2 billion per year.
This rounds off a good month for Gilead’s drug as it was also given FDA approval for patients with forms of chronic lymphocytic leukaemia, follicular lymphoma and small lymphocytic lymphoma in July.
The firm, which focusses predominately on virology and infectious diseases, also saw sales of its major hep C drug Sovaldi reach $3.5 billion in the second quarter, keeping talk of the medicine reaching $10 billion in its first year a real possibility.
This latest approval and recommendation for its new oncology product could also see the firm push more deeply into cancer – never an easy task, but one that could prove profitable for the company should it get it right.
New therapies
Chronic lymphocytic leukaemia affects around 3 in 10,000 people and follicular lymphoma 3.7 in 10,000 people in the European Union.
Treatments available generally induce remission, however the disease returns in nearly all patients. For follicular lymphoma, a need remains for new medicines for patients who have failed prior treatment.
The EMA says that Imbruvica and Zydelig both have the potential to bring new treatment options for patients suffering from these rare cancers, especially in cases where previous treatments have stopped working, as they act in different ways to other medicines already on the market.
The market for CLL is growing as last November, the FDA also approved Roche’s Gazyva (obinutuzumab) for the condition whilst Arzerra (ofatumumab), from GlaxoSmithKline and Genmab, had its licence expanded in April this year to include CLL.
Ben Adams
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