Johnson & Johnson (JNJ) subsidiary Janssen Biotech and Pharmacyclics (PCYC) have won approval from the US Food and Drug Administration (FDA) for their breakthrough therapy Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL).
Being jointly developed and commercialized by both the firms, Imbruvica is approved for MCL patients who have received at least one prior therapy and is based on overall response rate (ORR).
Imbruvica works by blocking a specific protein called Bruton's tyrosine kinase (BTK), a key signaling molecule of the B-cell receptor signalling complex that plays a major role in the survival of malignant B cells.
Safety and efficacy of Imbruvica were assessed in an open-label, multi-center, single-arm Phase II trial carried out in 111 patients with MCL who have received at least one prior therapy.
FDA awarded breakthrough therapy status to Imbruvica based on the 65.8% ORR and duration of response (DOR) of 17.5 months seen in the Phase II study of PCYC-1104 and the serious and life-threatening nature of MCL.
According to the company, tumour response was evaluated as per the revised International Working Group (IWG) for non-Hodgkin lymphoma (NHL) criteria.
FDA approval for Imbruvica comes just over four months after the New Drug Application (NDA) submission was completed in late June 2013.
Pharmacyclics CEO and chairman of the Board Bob Duggan said after observing early signs of efficacy and tolerability of Imbruvica four years ago, the company single-mindedly focused its attention on fully developing this medicine.
"Presently we are in the midst of investigating this medicine in numerous additional B-cell malignancies with 37 clinical studies ongoing," Duggan said.
The most common side effects reported in patients treated with Imbruvica include low levels of platelets in the blood, diarrhea, anemia, fatigue, musculoskeletal pain, swelling, upper respiratory infection, nausea, bruising, shortness of breath, constipation, rash, abdominal pain, vomiting and decreased appetite.
Other clinically significant side effects in patients are bleeding, infections, kidney problems and the development of other types of cancers.
Image: Johnson & Johnson world headquarters in New Brunswick, New Jersey, US. Photo: courtesy of Johnson & Johnson.