The Food and Drug Administration cleared the treatment for people with HER2-positive metastatic breast cancer, the agency said in a statement today. The therapy, previously named T-DM1, will be sold as Kadcyla. It combines Roche’s anti-cancer drug Herceptin with Waltham, Massachusetts-based ImmunoGen’s technology that helps the medication carry chemotherapy directly into malignant cells while bypassing healthy ones.
ImmunoGen said it will receive a $10.5 million payment for U.S. approval. The medicine is supposed to be more effective with fewer side effects than other therapies. It has the potential to be “one of the biggest biotech drugs,” generating worldwide sales of more than $5 billion, Simos Simeonidis, an analyst with Cowen and Co. in New York, wrote in a Jan. 25 note to clients.
“It’s in a way a super-Herceptin,” Sandra Horning, the head of global oncology at Basel, Switzerland-based Roche, said in a phone interview. “We see great potential for this molecule starting in the metastatic setting but with the potential to move into early breast cancer as well.”
ImmunoGen rose 1.9 percent to $14.57 at the close of New York trading. time. The shares increased 11 percent in the past 12 months.
Patients much first attempt treatment with Roche’s Herceptin before taking Kadcyla, the FDA said. Kadcyla will cost $9,800 a month with an estimated cost of $94,000 for a course of the treatment based on patients taking it for 9.6 months, according to a statement from Genentech Inc., the unit of Roche that developed the drug.
Kadcyla will be available to people in the U.S. within two weeks, South San Francisco, California-based Genentech said.
Roche, the world’s biggest maker of tumor medicines, is also testing T-DM1 as a first-line treatment for women with metastatic, or spreading, breast cancer. Herceptin generated almost $6.3 billion in 2012, according to data compiled by Bloomberg.
ImmunoGen said it will receive royalties from 3 percent to 5 percent. Worldwide royalties may generate $350 million for ImmunoGen in 2025, Simeonidis wrote.
About 12 percent of women in the U.S. will develop invasive breast cancer, according to the American Cancer Society. About 232,340 new cases of the disease will be diagnosed in women this year and about 39,620 women will die from breast cancer, according to the National Cancer Institute.
Kadcyla will carry a boxed warning that it can cause liver and heart toxicity and death. Pregnancy status also should be verified prior to starting the treatment because it can cause severe life-threatening birth defects, the FDA said.
A clinical study of 991 patients taking Kadcyla or GlaxoSmithKline Plc’s Tykerb, approved in 2007, showed patients taking Kadcyla lived a median 9.6 months without their disease progressing compared with 6.4 months for patients taking Tykerb, the FDA said.
T-DM1 is known as an antibody-drug conjugate. The antibody Herceptin and the chemotherapy DM1 target HER2-positive cancer cells. T-DM1 blocks the cancer cells from growing and destroys them by releasing the DM1.
“I hear so much coming from the physician community that they can’t wait to get their hands on this,” Daniel Junius, president and chief executive officer of ImmunoGen, said in an interview.
T-DM1 “opens up a whole new paradigm” as the first approval of an antibody-drug conjugate in a solid tumor, Junius said.
There are 10 antibody-drug conjugates in clinical trials using ImmunoGen’s technology, including the additional work on T-DM1. Three of the drug candidates are proprietary and wholly owned by ImmunoGen and being developed to treat lung and ovarian cancers and non-Hodgkin lymphoma. Roche is testing eight antibody-drug conjugates in early-stage trials and has 25 such molecules in its pipeline, Horning said.
ImmunoGen has partnerships with companies including Paris- based Sanofi and Amgen Inc., based in Thousand Oaks, California. The company plans to be selective about its technology and look to maintain more control over drug development, Junius said.
“Nobody’s perfect but I’d rather make my own mistakes,” Junius said.