Kadcyla - Roche/Genentech

Kadcyla (ado-trastuzumab emtansine)
Launch Date: February 2013
First-Year Sales: N/A
First-Half 2013 Sales: 83 million CHF ($91 million)
Analyst Estimate for 2018: $2.55 billion

Kadcyla's ascent hasn't exactly surprised the pharma world. After all, some were calling it "Super-Herceptin" before it even hit the market. And with Herceptin, the original HER2-positive breast cancer drug, pulling in 1.55 billion Swiss francs ($1.7 billion) in the last quarter alone, that's not a bad billing. When it launched this February, analysts were projecting peak sales between $2 billion and $5 billion a year.

So what was all the buzz about? Kadcyla represents an entirely new way to treat HER2-positive metastatic breast cancer. The "armed antibody" drug, known as T-DM1 in development, travels directly to tumor sites to shrink the cancer. In one Phase III trial, the drug delivered a 32% reduction in the risk of death when compared with the standard of care, and the median overall survival rate for patients taking the drug reached 30.9 months.

Kadcyla followed closely on the heels of Perjeta (pertuzumab), another Genentech drug that's tearing up Roche's ($RHHBY) top line. Roche hopes that Perjeta and Kadcyla will be used in tandem in patients with HER2-positive disease, possibly even before surgery. Perjeta recently grabbed a historic FDA approval for use as a neo-adjuvant treatment, becoming the first drug ever specifically approved for use before cancer surgery. Roche is studying Kadcyla for the very same use.

As expected, Kadcyla started raking in revenues right away. In July, Roche announced that it had hauled in 83 million Swiss francs, or about $91 million, for the first half of 2013. Together with the 108 million francs from Perjeta--plus 3 billion-plus for both Avastin (bevacizumab) and Herceptin (trastuzumab)--Roche's cancer drug sales earned analyst praise as a "blowout" result. 

Factoring into Kadcyla's sales to date was its hefty price tag, which it bears in common with many cancer-fighting counterparts. But Kadcyla is even pricer than its relatives. When it gained FDA approval, Roche pegged its monthly cost at $9,800, or about $94,000 for an average treatment. That's more than twice the price of Herceptin, which runs $4,500 per month. Perjeta goes for $6,000 per month.

But Roche knows what it's doing when it comes to cancer drugs. In addition to Herceptin, it also markets blockbusters Rituxan (for leukemia and rheumatoid arthritis) and Avastin (for several types of cancer, including colorectal cancer). The Swiss drug giant will be counting on newcomers like Kadcyla to pitch in as it readies itself for biosimilar competition to its older drugs; analysts expect biosimilars to land in the U.S. as early as 2015. 

For more:
Roche's new star Kadcyla picks up EU nod
Roche's Perjeta nabs speedy FDA nod in early breast cancer
FDA panel gives 'historic' thumbs-up for Roche's Perjeta in early breast cancer
Roche/Genentech's breakthrough T-DM1 wins blockbuster OK for breast cancer
FDA approves Roche's pricey new Herceptin partner, Perjeta

-- Carly Helfand (email | Twitter)

Kadcyla - Roche/Genentech