Pfizer secures expanded approval for Ibrance
pharmafile | April 3, 2017 | News story | Sales and Marketing | Pfizer, ibrance
Pfizer has announced that FDA has approved its supplemental New Drug Application (sNDA) for Ibrance, meaning that the drug is now permitted to be used alongside a broader range of aromatase inhibitors. In trials, Ibrance alongside letrozole was found to extend progression-free survival by more than 10 months.
The expanded indication includes patients suffering from postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.
The approval of the sNDA was based on Phase 3 trial data that displayed that median progression-free survival with the combination treatment extended beyond two years and displayed a 42% reduction in the risk of disease progression.
The trial involved 666 patients across 17 countries, with 23 months of follow up. Though the combined treatments offer hope for patients, the medications are not without risk. Pfizer relayed that there had been one death due to neutropenic sepsis, with neutropenia being the most common adverse event. The two trials displayed that 80% and 83% of patients experienced neutropenia as an adverse event.
The events, however, are not serious enough to outweigh the benefits that Ibrance, in combination, exhibits in patients.
“In the two years since its initial approval, Ibrance has been prescribed to more than 50,000 patients by more than 9,800 physicians in the US,” said Liz Barrett, Global President and General Manager, Pfizer Oncology. “This important update to the Ibrance label underscores the strength of the data we continue to generate for Ibrance. We are proud of the impact this innovative medicine continues to have on patients’ lives.”
Ben Hargreaves
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