The clinical trial of Pfizer’s Breast Cancer drug was halted due to efficiency problems. However, the problems have been resolved. The drug, known as Ibrance, headed through phase 3 of clinical trials.
The drug, in combination with fulvestrant, has already shown promising results. The drug, also known as Palbociclib, went through Phase 3 of PALOMA–3 trials and has met the primary outcome measurements. It has also demonstrated significant improvement in progression-free survival or PSF.
The senior vice president of Clinical Development and Medical Affairs, Mace Rothenberg, said that the results are significant. They aid in gauging how much potential the drug has to improve results in patients who are considered difficult to treat. He added that he was happy he had the chance to stop the trials to discuss their path moving forward with other officials.
The cancer patients involved in the trial displayed human epidermal growth factor receptor 2-negative and estrogen-receptor positive. Ibrance was used with fulvestrant or Faslodex, which is known for blocking estrogen. Patients who used the combination of the two drugs had more positive results than those who only used fulvestrant. Ibrance also surpassed the drug Novartis AG Femara in delaying the progression of breast cancer.
Now, Pfizer has to sit and wait for the decision of the regulatory boards to take the next step with the drug. Upon FDA approval, the drug could change the way breast cancer is treated.
Dennis Slamon, PALOMA-1 study co-author, said that the study “represents a potential practice-changing result.” Slamon added that “palbociclib will now become a standard treatment approach for postmenopausal women with ER+/HER2- metastatic breast cancer.”
Approval would also encourage Pfizer to speed up the trials in the breast cancer treatment study. They are still waiting for PALOMA-2 trials data.
Analysts predict that the drug may drive in $5 million of revenue for the company. Pfizer stock shares already raised nearly one percent, according to Pioneer News.
