CLDX will be next now that Roche/DNA gets T-DM1 approval......its a zero sum game w/ GPNMB targetting!
The FDA today approved T-DM1, a breakthrough antibody drug conjugate from Roche/Genentech widely expected to quickly become a new blockbuster treatment for breast cancer.
Roche ($RHHBY) will market the newly approved drug as Kadcyla. Its partner ImmunoGen ($IMGN) stepped up with the ADC technology and stands to gain a small, single-digit royalty stream from the therapy.
The drug will cost $9,800 a month,or about $94,000 for a 9.5-month course of therapy. Analysts' peak sales projections for this drug have ranged from $2 billion to $5 billion a year.
"Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer," said Hal Barron, Roche's chief medical officer and head of global product development.
In early October Roche revealed that the armed antibody delivered a 32% reduction in the risk of death among patients in the pivotal Phase III study when compared to the standard-of-care arm. The median overall survival rate for T-DM1 patients hit an impressive 30.9 months, while patients taking a combination of Tykerb and Xeloda achieved a 25.1-month OS rate.
T-DM1 has helped inspire a whole new wave of antibody-drug conjugates, many of which use technology from either ImmunoGen or Seattle Genetics. Roche/Genentech now has 25 ADCs in their pipeline, including 9 in clinical trials. And dozens more are in or near the clinic at other biopharma companies anxious to match T-DM1's targeting capabilities with a powerful drug payload.
"Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "It is the fourth approved drug that targets the HER2 protein."
Fewer people who received Kadcyla experienced severe side effects compared to those receiving standard therapy (40.8 percent vs. 57.0 percent), the FDA noted. But as expected a boxed warning will apply,noting that the drug can cause liver toxicity, heart toxicity and death. "The drug can also cause severe life-threatening birth defects, and pregnancy status should be verified prior to starting Kadcyla treatment."
"The biggest news in today's press release, given that approval was expected, was that the label allows for use in front-line HER-2 positive metastatic breast cancer," says Cowen's Simos Simeonidis in a note this morning. "This was not a major surprise, since EMILIA included about 12% front-line mBC patients (about 60 1st-line mBC patients in the T-DM1 arm of the EMILIA trial), but it was definitely not a given."
Frank- you are the man today. This is actually huge news. CDX-011 is absolutely in the same boat. That doesn't gaurantee anything, but look at the data used by Genentech to get breakthrough status. sound familiar ? Also, $94,000 for course of treatment of life-saving medication will work just fine . . . .
"Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.
FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.
Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs. "
Nice. Proves the technology can warrant breakthough status and we are loaded for bear in this area, too. CDX-011 could (should) get same treatment at any time, then recent run up will look like a small blip on the cahrt compared to what follows. Could this be a hidden "goodie" coming ahead of the conference call? Our data is just as compelling for GPNMB+ breast cancers, plus we have the companion diagnostic to identify patients highly likely to benefit. Here comes the Win-Win for Celldex and triple negative breast cancer patients!
However, side effect warnings of such extreme nature will be mostly likely Not required given what we know to date, there are no potential adverse effects or contradindications, which just makes it that much more marketable and desirable, let alone PFS and OS will be follow similar larger trial,
this will be outstanding. Hence the box warning below will be most probably not necessary:
But as expected a boxed warning will apply,noting that the drug can cause liver toxicity, heart toxicity and death. "The drug can also cause severe life-threatening birth defects, and pregnancy status should be verified prior to starting Kadcyla treatment."