As its oncology stalwart Herceptin prepares for a rush of biosimilar competitors, Roche has high hopes for another horse in the HER2-positive breast cancer space. And now, Kadcyla’s ready to run in a new indication.
Monday, the FDA approved Kadcyla for adjuvant treatment of HER-2 positive, early breast cancer patients who didn’t fully respond to drug therapy before surgery. With a new indication in hand, Kadcyla can help back up Roche’s longtime breast cancer blockbuster Herceptin, which faces biosimilar competition later this year.
Roche said the new Kadcyla nod adds an important postsurgery treatment for early breast cancer patients—and the approval came hard on the heels of new data, thanks to a new and faster FDA review pathway.
“By working closely with the FDA and participating in the Real-Time Oncology Review pilot program, we are able to make Kadcyla available for people with residual invasive disease after neoadjuvant therapy much sooner than anticipated,” Roche medical chief Sandra Horning said in a release.
The drug’s newest approval follows a round of phase 3 clinical data released in December showing “remarkable” results in treatment of breast cancer patients after Herceptin.
Among 1,500 patients treated with either Herceptin or Kadcyla, an "armed antibody" that contains Herceptin and chemotherapy drug DM1, those treated with Kadcyla showed an 11% improvement in fending off recurring disease or death. Jakob DuPont, Roche's former global head of breast and gynecologic cancer development, said an improvement of 2% to 3% is considered clinically promising for that measure.
Those clinical results could give Kadcyla a boost in the HER2-positive breast cancer market and eclipse its history as a sales underperformer for Roche.
Since its slower-than-expected 2013 launch, Kadcyla built up to CHF 979 million ($960 million) in 2018 sales—and that's still a fraction of the CHF 6.89 billion ($6.76 billion) Herceptin raked in during the same time period. Kadcyla showed more signs of life in the first quarter of this year with a 24% increase in global sales to CHF 291 million.
By contrast, Roche’s other next-generation oncology drug Perjeta has seen skyrocketing sales after its pre- and postsurgery approvals for HER-2 positive breast cancer. In the first quarter alone, Perjeta cleared CHF 868 million in global sales, an impressive 41% jump.
Meanwhile, despite its continued lead as Roche’s sales blockbuster to beat, Herceptin’s performance has shown signs of cracking as biosims approach the U.S. market.
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Herceptin pulled in CHF 1.7 billion in global sales in the first quarter, a 6% decrease year over year. While the drug’s U.S. sales actually saw 3% growth during the same period, Roche is expected to lose ground to Herceptin’s first biosim competitor, Mylan and Biocon’s Ogivri, which is slated to launch stateside this year under a settlement with the Swiss drugmaker.
Though Roche has fought tooth and nail to keep them off the market, the FDA recently approved two more Herceptin biosimilars, Pfizer’s Trazimera and Samsung’s Bioepis, which are still tied up in litigation with Roche.