ZURICH (Reuters) - Swiss drugmaker Roche has won fresh approvals for two cancer drugs in Europe and the United States, shoring up its position in new medicines as it braces for falling sales of older products.
The European Commission approved Alecensa as a treatment for a mutated form of lung cancer called ALK-positive, the company said on Thursday, while U.S. regulators backed Perjeta for use in certain early-stage breast cancer patients after surgery.
The EU decision had been expected following a positive recommendation in October from experts, after evidence showed patients taking the targeted lung cancer drug had a lower risk of disease progression or death than those on Pfizer’s rival product Xalkori.
The U.S. green light for Perjeta in combination with Herceptin and chemotherapy for treating HER2-positive early breast cancer after surgery follows a clinical trial that demonstrated a modest benefit.
That trial had disappointed investors when results were announced in June, but Roche had continued to express confidence in the medicine’s prospects.
Analysts at Jefferies said U.S. Food and Drug Administration’s (FDA) approval for expanded Perjeta use came about a month earlier than anticipated and the stipulations around its use were better than expected.
Based on a survey of oncologists, Jefferies expects U.S. cancer doctors to use Perjeta in 44 percent of post-surgery, or adjuvant, patients currently treated with Herceptin, which translates into a revenue opportunity of around $4.3 billion.
The FDA also granted full approval of the Perjeta-based regimen in pre-surgery, or neoadjuvant, treatment, which Jefferies said could add more than $1 billion.
Roche is at a critical juncture, after years of strong sales growth, because its older cancer drugs are about to face competition from cheaper so-called biosimilar versions.
Chief Executive Severin Schwan told Reuters this month the impact from biosimilars would be significant but that the pipeline of new products had been “de-risked”, enabling the company to compensate for this erosion.
Reporting by Brenna Hughes Neghaiwi and Ben Hirschler; Editing by Edmund Blair