FDA gives nod to drug that prevents breast cancer recurrence
Puma Biotech has pounced to secure FDA approval for its extended adjuvant treatment for early-stage, HER2-positive breast cancer. The drug, Nerlynx (neratinib), gains the nod from the agency despite there being some concerns about the side-effects.
In particular, the agency was concerned with the level of diarrhoea experienced by patients, as it is listed as a common side-effect and means that patients will have to receive the drug in a cycle of 56 days, after which it is used as needed. Patients may also need to stop treatment if they experience Grade 4 diarrhoea or Grade 2 diarrhoea after the maximum dose received is lowered.
However, the positives were found to outweigh these negatives when the full data was presented to the agency. In clinical trials, 2,840 patients were measured over a two year period to determine whether the drug was able to prevent recurrence of HER2-positive breast cancer. The results found that 94.2% of patients did not experience cancer recurrence or death, compared against 91.9% of those receiving placebo.
The marginal benefits were enough for the agency to approve the drug, providing HCPs with an option to provide those with a risk of recurrence the treatment.
“Despite advances in the treatment of early stage HER2-positive breast cancer, there remains a need for further therapeutic improvements in order to attempt to further reduce the risk of disease recurrence,” said Puma Biotechnology CEO and President Alan H. Auerbach. “We are pleased to be able to bring this new medicine to patients with breast cancer. We would like to express our appreciation to the patients, caregivers and physicians who contributed to the neratinib clinical development program and, more specifically, the ExteNET trial.”
The drug is predicted to secure sales of $1.25 billion by 2022 and could forecasts reach as a high as $6 billion in peak sales. Puma announced that it expects to reach the market by the end of September.
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