Clinical trials waived for Pfizer's breast cancer drug

Palbociclib, a potential blockbuster drug developed by Pfizer that significantly increases the rate of surviving HER2 negative breast cancer, has been granted a waiver of clinical trials by the health ministry's apex committee. The company has been issued marketing approval on the condition that it will conduct phase IV trials on 100 patients within 15 months and submit the data.

"Palbociclib is under the regulatory approval process. It is premature to detail the specifics of its launch. We are working to bring this drug to patients in India at the earliest possible," the Pfizer spokesperson said.

According to GlobalData, an international market research company, the market size for therapeutics to treat HER2 negative breast cancer will increase from $1.45 billion in 2013 to $6.12 billion by 2023 as the treatment moves away from chemotherapy to hormone therapy.

"Unlike the HER2 positive breast cancer market, which is dominated by Roche, the HER2 negative market has no clear cut leaders. Palbociclib will clearly be the market leader, largely due to the fact that it will be the first-to-market drug in its class," said GlobalData in its report of January last year.

It also said of a total 853.9 million breast cancer patients in 2013, around 652.9 million were suffering from HER2 negative breast cancer.

The government's apex committee took this decision in April based on the recommendation by the technical committee. The drug approval process in India involves three committees, a subject expert committee, a technical committee and the apex committee.

According to analysts, the drug is expected to have global sales of $2-5 billion by 2020. The drug was approved by the US FDA as a breakthrough therapy to treat HER2 negative breast cancer.

Pfizer first submitted the clinical trial data of other countries to the subject expert committee, requesting it for the waiver of clinical trials here. "It was observed that progressive free survival is almost double that of the comparator drug Letrozole (manufactured and sold by Novartis)," said the subject expert committee in its recommendation to the technical committee.

The subject expert committee said Pfizer should be granted marketing approval on the condition it would conduct phase IV trials on not less than 100 patients. It added the company should submit the data within one year from the date its trial protocol was approved.

After detailed deliberations, the technical committee recommended the waiver. The apex committee agreed to the technical committee's recommendation in April.

CURING CANCER ONE STEP AT A TIME

• The company says the drug is under regulatory approval process
   
• The market size for therapeutics to treat HER2-negative breast cancer will increase from a value of $1.45 billion in 2013 to as much as $6.12 billion by 2023
   
• Unlike the HER2-positive breast cancer market, which is dominated by Roche, the HER2-negative market currently has no such clear-cut leaders
   
• Palbociclib is expected be the market leader, largely due to the fact that it will be the first-to-market drug in its class