Project name: T-DM1
Disease: Breast cancer
Peak sales estimate: $2 billion to $5 billion
Approved: Feb. 22
Companies: Roche and ImmunoGen
After wowing the industry in 2012 with its breast cancer treatment Perjeta, Roche ($RHHBY) and its biotech unit Genentech got an early 2013 approval for T-DM1, brand-named Kadcyla. With Kadcyla, Roche has another breakthrough antibody-drug conjugate (ADC) that presents a new way to treat HER2-positive metastatic, or late-stage, breast cancer. The ADC technology from partner ImmunoGen ($IMGN) delivers the drug to the cancer site, where it shrinks the tumor, slows the progression of the disease and so extends life.
In the EMILIA trial, patients lived on average 30.9 months after starting the drug, almost 6 months longer than the overall survival rate of 25.1 months for patients taking a combination of Tykerb and Xeloda. They also had fewer severe side effects compared with those receiving standard therapy. The FDA evaluated the drug under its priority review program, which allows for an expedited 6-month review for drugs whose benefits make them worth getting in the hands of doctors ASAP.
The kinds of results that Kadcyla produces can command premium pricing. Its monthly price of $9,800, coming to about $94,000 for an average treatment, is significantly more than the initial $6,000 monthly cost for Perjeta, a Roche ADC that has been so effective in treating late-stage breast cancer that the FDA last year gave it a historic approval, allowing it to be used even before surgery. Roche is studying Kadcyla for the very same use. Kadcyla's price is more than twice the $4,500 price of Herceptin, whose mantle it is expected to wear as biosimilar competition hijacks Herceptin's sales.
In fact, Kadcyla was dubbed the "super-Herceptin" by some even before its approval because in trials its benefits were beating those of its predecessor. The super-Herceptin is helping supercharge the Swiss drugmaker's financial results and helping its cancer portfolio hold on to its leading-edge reputation.
But Kadcyla has done more than boost the confidence of Roche. The buzz around the drug was so intense that it inspired a raft of new ADCs, as well as deals and manufacturing projects. Roche itself will spend $200 million on a new ADC manufacturing facility in its hometown of Basel to help manufacture drugs like Kadcyla, as well as some of the 25 ADCs in the Roche/Genentech pipeline, assuming they also snatch approvals. Dozens of ADCs are being developed at other biopharma companies that are turning to the technology of ImmunoGen, as well as Seattle Genetics ($SGEN), in hopes of achieving the kind of treatment results, as well as the financial goods, that Kadcyla is reaping.
But the technology is not without risks. After getting loads of attention for helping Roche with Kadcyla, ImmunoGen halted a Phase II study of its own lead pipeline therapy in November after researchers determined that patients in the drug arm experienced a higher risk of infection and one cancer patient died from an infection which was possibly drug-related. -- Eric Palmer (email | Twitter)
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