Two months after Roche unveiled clinical trial data that could help bring its breast cancer drug Kadcyla to early-stage patients, the company has won a speedy FDA review. And if Roche succeeds, it may start to quiet critics who've long questioned whether the company can continue to grow in the face of mounting biosimilar competition to its biggest blockbusters, including breast cancer drug—and Kadcyla predecessor—Herceptin.

Roche said Tuesday it had filed to the FDA to expand Kadcyla use to HER2-positive early breast cancer patients who don’t fully respond to drug therapy before surgery—and that the FDA is reviewing the request under its Real-Time Oncology Review and Assessment Aid pilot program.

It's Roche’s first drug to be reviewed under that program, which allows the agency to start analyzing trial data as soon as it becomes available, rather than waiting for the company’s formal application.

The real-time review, coupled with the breakthrough therapy designation the FDA also granted to Kadcyla in early breast cancer, could yield a decision on the expansion within weeks. During Roche’s fourth-quarter conference call in mid-January, Roche Pharmaceuticals CEO Bill Anderson said a decision could come "very soon in Q1, and shortly thereafter in Europe."

At the San Antonio Breast Cancer Symposium in December, Roche presented the data from its phase 3 Katherine trial, a head-to-head test of Kadcyla versus Herceptin in 1,500 patients. Kadcyla lowered the risk of recurrence or death in HER2-positive early-stage patients with residual disease by 50% compared with its predecessor, the data showed. Three years after the treatment, Kadcyla had lowered the risk of recurrence by 11%.

The ability to expand Kadcyla’s use to early-stage patients who don’t fully respond to drugs would represent "a new treatment option for these patients who have a worse clinical outcome in that potentially curable setting," Roche's global head of breast and gynecologic cancer development, Jakob Dupont, told FiercePharma in December.

It might also give a much-needed boost to Kadcyla, an armed antibody that combines Herceptin with a chemotherapy treatment called DM1. Analysts initially expected the drug to be racking up annual sales of $5 billion, but it has a steep climb to get there. Sales of the product rose 8% in 2018 to $979 million.

Kadcyla is one of the new products Roche has been counting on to cushion the blow of biosimilar competition that’s starting to hit not just Herceptin, but two of its other oncology blockbusters, Avastin and Rituxan. Herceptin biosimilars grabbed 14% of the European market in their first seven months on the market, Bernstein analyst Ronny Gal noted in January. That was even faster biosimilar adoption than was seen with Roche’s Rituxan.

Biosimilar adoption rates have been slower overall in the U.S., but that could change, Gal predicted, as insurers adopt new rules requiring patients to start on lower-cost drugs before progressing to more expensive alternatives.

In November, the FDA approved the first Rituxan biosimilar, Truxima from Celltrion and Teva. Roche told investors to expect a hit to sales as soon as the second half of this year, but the company didn’t provide many details.

When asked during the fourth-quarter conference call to predict the level of sales erosion Roche expects this year on U.S. biosimilars, Anderson said there were too many variables, including ongoing patent litigation.

"[N]obody knows exactly what's going to happen and how it's going to play out," he said. "So I think there's that level of uncertainty, and then the other level of uncertainty is what will the uptake be when they arrive."

Register as Visitor to CPhI China 2019!