Janssen/Pharmacyclics gain FDA nod for Imbruvica
pharmafile | November 14, 2013 | News story | Sales and Marketing | FDA, Janssen, Pharmacyclics, Revlimid, Velcade
The FDA has approved Janssen and Pharmacyclics’ Imbruvica to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.
Imbruvica (ibrutinib) now has a licence for patients with MCL who have received at least one prior therapy, and works by inhibiting the enzyme needed by the cancer to multiply and spread.
This marks the second drug that has received the FDA’s new breakthrough therapy designation to gain approval – the first was Roche’s blood cancer drug Gazyva which was shown the green light earlier this month.
This designation is intended to speed up the FDA’s processes, and the drug’s approval was based on mid-stage trials rather than Phase III studies, in order to get it onto the market swiftly.
Final trials will produce results in the first half of 2014 in chronic lymphocytic leukaemia (CLL) the firm said, and later that year (or in 2015) for MCL.
Imbruvica is the third drug approved to treat MCL in the US after Takeda’s Velcade (bortezomib) and more recently Celgene’s Revlimid (lenalidomide).
Although third to market Imbruvica may have the edge, as it is believed to be more tolerable than traditional combination medications for cancers, which can cause serious side effects such as low red cell counts requiring blood transfusions.
Peak worldwide sales for the pill may reach as much as $6.5 billion in 2026 if it’s approved for more cancers, with $3 billion from the US alone said Michael Yee, an analyst with RBC Capital Markets in a note to clients this week.
Bob Duggan, chief executive and chairman of the board of Pharmacyclics, said: “The approval of Imbruvica marks significant progress toward Pharmacyclics’ goal of serving as an ally to patients. After observing early signs of efficacy and tolerability of [the drug] four years ago, we single-mindedly focussed our attention on fully developing this medicine.
“We continue to explore Imbruvica’s potential to treat cancer patients in need. Presently we are in the midst of investigating this medicine in numerous additional B-cell malignancies with 37 clinical studies ongoing.”
Pharmacyclics said in July it would be eligible for a $350 million payment from partner Janssen – the pharmaceutical unit of Johnson & Johnson – upon approval.
“Imbruvica’s approval demonstrates the FDA’s commitment to making treatments available to patients with rare diseases,” said Richard Pazdur, director of the office of haematology and oncology products at the FDA.
He added: “The agency worked co-operatively with the companies to expedite the drug’s development, review and approval, reflecting the promise of the breakthrough therapy designation programme.”
MCL is a rare form of non-Hodgkin lymphoma and represents about 6% of all non-Hodgkin lymphoma cases in the US. By the time MCL is diagnosed, it usually has already spread to the lymph nodes, bone marrow and other organs.
Ben Adams
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