2011: A Year of Firsts in Oncology

Quality and Quantity

Sometimes in turning over a new calendar year, we don’t take the time to appreciate all that has happened to get us where we are today. We’re more than half way through January and already the highlights of 2011 seem like a distant memory. In catching up with the events of 2011, in some respects, its been a great year for the oncology industry.

There were several “firsts” in 2011, but perhaps what is inspiring from 2011 is the quality of firsts in the approvals of new cancer treatments. With the U.S. Food and Drug Administration’s approval of the immunotherapy, Yervoy, in March, BMS holds the distinction of developing the first FDA-approved drug shown to prolong the lives of people with melanoma. A few months after the approval of Yervoy, Roche announced the approval of Zelboraf (vemurafenib; Genentech)—the first and only FDA-approved personalized medicine shown to improve survival in people with BRAF V600E mutation-positive metastatic melanoma—and touted with it, a first-of-a-kind test called the cobas 4800 BRAF V600 Mutation Test—a companion diagnostic that will help determine if a patient’s melanoma cells have the mutation.

In a NSCLC first, Xalkori (crizotinib; Pfizer) was approved in August 2011 for a subset of late-stage NSCLC patients who express the abnormal anaplastic lymphoma kinase (ALK) gene. It, too, comes with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene. It is estimated that 4%-7% of NSCLC patients have the mutation, and the genetic test—Vysis ALK Break Apart FISH Probe Kit—is another first-of-a-kind to help make the determination.

Since diagnostic tests help to identify which patients are most likely to benefit from a treatment, while sparing others from unnecessary side effects and cost, pressure is mounting for companies to develop diagnostic tests along with new drug approvals, thereby accelerating the promise of personalized medicines in oncology.

In 2011, we also saw some firsts where there hadn’t been any before. For instance, the first and only treatment indicated for patients with myelofibrosis – Jakafi (ruxolitinib; Incyte) was approved. And, we also saw the first new drug in more than 30 years to be approved for treatment of relapsed or refractory Hodgkin’s lymphoma, as well as analplastic large cell lymphoma (Adcetris; Seattle Genetics, Inc). It is also well worth mentioning that a kinase inhibitor, vandetanib (Caprelsa; AstraZeneca), was approved and launched without waiting for trade name approval since there were no other FDA-approved medicines available for this type of rare medullary thyroid cancer.

It may not fit nicely into a first category, but Zytiga (abiraterone; Johnson & Johnson) was approved in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer in men who have received prior docetaxel chemotherapy, and helped personalized medicine in oncology gain momentum. Perhaps we can call it the first new drug to challenge Provenge and Taxotere in prostate cancer.

But At What Price?

But as we move into this new technological age, these personalized advancements come with a high price. Perhaps the most shocking is the $120,000 BMS is charging for a complete course of Yervoy treatment—four infusions over a three-month period. But, regarding price, there’s also positive news. The cost for patients receiving Roche’s Zelboraf is less than half of Yervoy (depending on the course of treatment) with a monthly price tag of roughly $9,400, making a 6-month course of treatment $56,400.

Similar to the Zelboraf price is Xalkori which stays under the $10,000 a month range with a cost of $9,600, while Jakafi is expected to cost $7,000 per month, or $84,000 for a year’s supply. Seattle Genetics announced that the price of its drug, Adcetris, would be $13,500 per dose. Analysts have estimated a course of treatment with the drug to range from $94,000 to $121,500. Maybe this is the first year we’ve seen a product come out with a price tag that is half the cost of its competitor (Zelboraf vs Yervoy)—thank you companion diagnostics, subsets of patients, and responsible companies.

Comparing 2011 to 2010, there were several more label expansions in 2010 than there were in 2011, but no matter how you cut it, we saw maturation of the personalized oncology pipeline and great clinical progress in 2011. I’m looking forward to the continued advancements in personalized medicines in 2012.

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  1. So the critical question is, whether the diagnostic tests that are helping to usher in the new era of personalized medicine accompanying targeted therapies will doom chemotherapy to a more rapid obsolescence, or will it force the chemo manufacturers to develop their own diagnostic tests?

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