FDA gives Perjeta priority
pharmafile | July 3, 2013 | News story | Sales and Marketing | FDA, Perjeta, Roche, breast cancer
The FDA has granted priority review status to an application for Roche’s Perjeta to be used before surgery in HER2-positive early-stage breast cancer.
Perjeta (pertuzumab) is already in use for patients whose disease has advanced, and the US regulator says it will make a decision on Roche’s supplemental biologics license application by the end of October.
Considering the drug as a neoadjuvant treatment – that is, an option given before surgery – could open up a lucrative new area for Roche.
There are currently no such FDA-approved treatments for cancer, and the idea in this instance would be to use it to reduce a tumour’s size so it may be easier to remove, or to make breast-conserving surgery possible.
“The impact of treatment in breast cancer is greatest in the early-stage, before the cancer has spread to other parts of the body,” said Hal Barron, Roche’s chief medical officer.
“We look forward to working with the FDA to bring this potential option to people with HER2-positive early-stage breast cancer as soon as possible,” he said.
Perjeta was approved in March in Europe and in the US last year in combination with Roche’s own Herceptin (trastuzumab) and docetaxel chemotherapy for patients with previously untreated HER2-positive metastatic breast cancer (mBC).
The new application is based mainly on results from NEOSPHERE and TRYPHAENA, two Phase II studies in early-stage breast cancer.
And it calls on long-term safety data from the Phase III CLEOPATRA study – which also showed this regimen helped reduce the risk of death by 34% versus Herceptin and chemotherapy alone.
In addition, CLEOPATRA showed the combination extended progression-free survival by 6.1 months from 12.4 months (for those just on Herceptin and chemotherapy) to 18.5 months.
Perjeta and Herceptin are believed to be complementary because they target different places on the HER2 receptor, a protein found in high quantities on the outside of cancer cells in HER2-positive cancers.
Roche is hoping that Perjeta, which will make a predicted $1.8 billion in peak annual sales, will help cushion the impact of Herceptin’s imminent loss of patent protection.
Adam Hill
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