Speedy FDA nod for Amgen leukaemia drug
pharmafile | December 5, 2014 | News story | Research and Development, Sales and Marketing | B-cell lymphoblasts, FDA, Kyprolis, blinatumomab, blincyto, leukaemia
The FDA has approved Amgen’s Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukaemia (B-cell ALL).
The FDA has given Amgen’s rare leukaemia drug the green light more than five months ahead of schedule, and is the first drug approved that absorbs T-cells to terminate leukaemia cells for patients whose cancer has returned, or who have not responded to previous treatment.
“Immunotherapies, especially Blincyto with its unique mechanism of action, are particularly promising for patients with leukaemia,” says Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Centre for Drug Evaluation and Research.
“Recognising the potential of this novel therapy, the FDA worked proactively with the sponsor under our breakthrough therapy designation program to facilitate the approval of this novel agent,” Pazdur continues.
Acute lymphoblastic leukaemia (ALL) accounts for more than 12% of leukaemia, and out of the 42,000 diagnosed with the disease each year 31,000 are expected to die from it. In adults with relapsed or refractory ALL, median overall survival is only three to five months.
“There is a high unmet need for new medicines to treat relapsed and refractory ALL patients, who have very few treatment options,” says Sean Harper, executive vice president of R&D at Amgen.
B-cell is an uncommon form of ALL in which the bone marrow makes too many B-cell lymphoblasts, and according to the National Cancer Institute, 6,020 people in the US alone will be diagnosed with ALL in 2014 and 1,440 will have died from the disease.
During the clinical study conducted, Blincyto showed a ‘substantial improvement’ over available therapies in terms of treatment. Of the 185 patients taking part 32% experienced complete remission for over six months – after at least four weeks of infusion.
A major drug in Amgen’s late-stage pipeline, Blincyto came as part of the $1.16 billion acquisition of German biotech firm Micromet in 2012. A marketing authorisation application has also been submitted to the EMA to file the drug in Europe.
Earlier this year the US biopharma firm had less luck in seeking treatment approval when its rare cancer drug Kyprolis (carfilzomib) failed in a late-stage trial, just a year after the firm spent $10.4 billion to acquire its manufacturer, Onyx.
Originally predicted to make $3 billion a year by 2021, the medicine was unsuccessful in improving the overall survival when compared to patients using a low-dose dexamethasone, or equivalent corticosteroids, a class of chemicals that includes steroid hormones.
The study, aptly named Focus aimed to demonstrate that the treatment helped patients live longer, but what it showed was an increase of renal adverse events in patients taking Kyprolis compared to those who were not.
Commenting on the approval of Blincyto, Anthony Stein, clinical professor, Hematology/Oncology at City of Hope concludes: “The approval of the drug represents a significant milestone in immunotherapy research, providing clinicians the opportunity to offer a new single-agent therapy to patients fighting this highly aggressive cancer with previously limited options.”
Analysts at EP Vantage add: “Amgen’s new cancer drug Blincyto will not be a record-breaker in generating sales, but it may be remembered for another accomplishment: one of the fastest approvals on record.”
Tom Robinson
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