Spectrum wins FDA approval for rare cancer drug
pharmafile | July 4, 2014 | News story | Research and Development, Sales and Marketing | Beleodaq, Cancer, FDA, Spectrum, non-Hodgkin lymphoma
In an expedited review the FDA has approved a new cancer drug from Spectrum Pharmaceuticals to treat a rare cancer of the lymph nodes.
Beleodaq (belinostat) is now approved for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).
This is the second medicine from the firm to treat the disease after the 2009 approval of Folotyn (pralatrexate) for use in patients with relapsed or refractory PTCL. The drug made $44.4 million last year.
The approval came under the umbrella of the agency’s ‘accelerated approval programme’ that speeds up the overall review process for new medicines, in order to help patients with an unmet medical need.
PTCL comprises a diverse group of rare diseases in which lymph nodes become cancerous. In 2014, the National Cancer Institute estimates that 70,800 Americans will be diagnosed with NHL and 18,990 will die.
Beleodaq works by stopping enzymes that contribute to T-cells, a type of immune cell, becoming cancerous. It is intended for patients whose disease returned after treatment (relapsed) or did not respond to previous treatment (refractory).
“This is the third drug that has been approved since 2009 for the treatment of peripheral T-cell lymphoma,” says Richard Pazdur, director of the office of haematology and oncology products at the FDA.
“[This] approval expands the number of treatment options available to patients with serious and life-threatening diseases.”
The third medicine from this list is Celgene’s Istodax (romidepsin) that gained accelerated approval in 2011 for the treatment of PTCL in patients who received at least one prior therapy. This drug also made around $40 million in sales last year.
The approval for Spectrum is also good news for Denmark’s Topotarget, the firm that originally developed the drug. The Danish biotech firm can now receive a $25 million milestone as it prepares for its upcoming merger with BioAlliance Pharma.
Spectrum signed a deal with Topotarget in 2010, paying $30 million upfront and agreed to pay up to $320 million in milestones, along with a million shares of stock and royalties on sales.
Spectrum acquired the rights to sell the drug in North America and India along with an option on China.
Ben Adams
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