Puma Biotech’s breast cancer drug gets FDA committee nod
pharmafile | May 25, 2017 | News story | Medical Communications, Sales and Marketing | Puma Biotech, breast cancer, neratinib
Puma Biotechnology breast cancer drug that could be used to reduce the risk of disease recurrence has been boosted by an FDA advisory committee nod. The vote count came in at 12 to 4 in favour of the drug, despite doubts over its potential side-effects and the limited number of people it could benefit.
The drug, neratinib, was given the thumbs up on the basis of its use in patients who were in remission after treatment by Herceptin and chemotherapy. The treatment was able to display benefits to disease-free survival after two years of 2.3% when compared with placebo; cancer returned in 5.8% of women who took the drug against 8.1% who were on the placebo arm of the trial.
Patients were specifically chosen for the trial if they tested positive for the receptor HER2. Some on the panel recommended that for its initial approval, it should be limited to patients who displayed both HER2 and an estrogen receptor known as ER+ − in whom patients the drug was most effective.
The committee noted that the clinical trial finding of diarrhoea as a common side-effect was worrying, as close to 40% of patients treated suffered from grade-3 diarrhoea. This level is severe enough that it can require treatment and would likely see patients need to take a further medication to negate the unwanted symptoms.
Despite the negatives, the drug was enough to gain the committee’s approval and the news, despite the odds against it, buoyed Puma. The news also had a positive impact on the share price of the company, with an immediate increase of 28% after the decision was released.
Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, reacted to the decision by releasing a statement: “Despite advances in adjuvant therapy for HER2-positive breast cancer, disease recurrence remains a risk. Since there are no effective therapies for patients whose disease recurs, there is an important need for additional options to further reduce the risk of recurrence”.
Ben Hargreaves
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