FDA extends licence for Janssen’s Imbruvica
pharmafile | February 13, 2014 | News story | Sales and Marketing | FDA, Janssen, durect, imbruvica, leukaemia
Janssen and partner Pharmacyclics have been given an extended FDA approval for their new blood cancer treatment Imbruvica.
The US regulator has said yes to Imbruvica (ibrutinib) for chronic lymphocytic leukaemia (CLL) sufferers who have received at least one previous therapy.
This marks the second approval for the pill, as in November 2013 it won US approval to treat a rare and aggressive form of non-Hodgkin lymphoma called mantle cell lymphoma in patients who have received prior treatment with at least one other therapy.
There had been some disappointment from analysts when the original approval of the drug did not include both types of cancer.
RBC Capital Markets analyst Michael Yee has been forecasting peak annual sales of $5 billion for Imbruvica – up from the $3 billion he forecast back in November.
“Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” said Richard Pazdur, director of the office of haematology and oncology products at the FDA.
The pill was fast-tracked through the FDA’s accelerated approval system, and this latest licence for Imbruvica is based on a relatively small clinical study of just 48 previously treated participants.
Results showed nearly 58% of patients in this trial had their cancer shrink after treatment (known as overall response rate, or ORR). At the time of the study, the duration of response ranged from 5.6 to 24.2 months.
An improvement in survival or disease-related symptoms has not yet been established, however.
CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells called B lymphocytes, or B cells.
The National Cancer Institute estimates that 15,680 Americans were diagnosed and 4,580 died from the disease in 2013. Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide.
Pain for Durect Crop
Meanwhile in a separate decision, the FDA has declined to approve Durect Corp’s post-operative pain treatment Posidur (saber-bupivacaine), saying the company’s application ‘lacked enough data’ to prove its safety.
Shares in the firm plummeted following the news, falling around 30% yesterday. The FDA indicated that more clinical safety studies would have to be conducted on the drug, Durect said in a statement.
The speciality pharma company added that it was now evaluating the issues described in the FDA’s complete response letter.
Ben Adams
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