After the efficacy problems regarding Pfizer’s breast cancer drug were solved, a new clinical trial gave Ibrance preliminary approval.
Also known under the name of Palbociclib, the drug Ibrance, went through Phase 3 of PALOMA – 3 trials study and has met the primary outcome measurements and also displayed improvement in PFS (progression-free survival). Pfizer’s drug was used in combination with fulvestrant.
The senior vice president of Clinical Development and Medical Affairs, Mace Rothenberg, explained that the results are important because they help with understanding the potential Ibrance has an also improve the results in patients which suffer from difficult-to-treat cancer. He confessed that he was glad to have the opportunity to stop the trial early and discuss a regulatory path forward with other health authorities.
The cancer patients who took part in the study exhibited human epidermal growth factor receptor 2-negative and estrogen-receptor positive. Ibrance was used on the subjects in combination with Faslodex (fulvestrant), a drug which is extensively used for blocking estrogen. Patients who took this combination of medicine showed better results than those who used only fulvestrant.
Pfizer’s Ibrance was even able to delay breast cancer progression more effectively than Novartis AG Femara drug. Now the company has to wait for the response of the regulatory boards.
After the drug received approval, PhD Dennis Slamon, PALOMA-1 study co-author, commented:
“With the FDA approval, this study represents a potential practice-changing result. I believe palbociclib will now become a standard treatment approach for postmenopausal women with ER+/HER2- metastatic breast cancer.”
Chris Schott, an analyst from JPMorgan Chase & Co., expects great sales for Ibrance once it is available on the market. The successful trial will make the drug productive on the market. Schott estimates that the company will gain $ 5 billion with this new drug. Pfizer stock shares have already went up almost one percent.
The company is still waiting for PALOMA-2 trials data, but this approval should help the drug trials to accelerate.
In the meantime other pharmaceutical companies are working on developing medicine which can stop cyclin-dependent kinases 4 and 6.
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