A medicine which first received notariety at the American Society of Clinical Oncologists (ASCO) this summer was approved by the FDA today. This drug is the first in a new family of medicines called anti-CTLA 4 inhibitors. Yervoy (ipilimumab) also known as "ipi", works to rev up the immune system against melanoma (changes the donward regulation of T cells to an upward direction).
It is crucial to understand that melanoma has a variety of characteristics and this drug works against one aspect to prolong survival and is the first to have shown to improve survival in advanced melanoma. Beyond this first approval, Yervoy is being studied in:
1) Fighting castration resistant prostate cancer (results expected in 2012)
2) Adjunctive therapy to melonama resection (results in 2015 or so)
3) First line treatment of squamous non-small cell lung cancer (results expected in January 2015 or so)
It is expected that this medicine may also be used sequencially or in combination with other agents to fight escape of melanoma cells which are notorious for spreading (metastasizing) to other part of the body.
Additional targets in melanoma include specific gene changes (BRAF, BRAF 600 V, 600 E and others such as 597). A new family of medicines called BRAF inhibitors is being studied. Melanoma and other cancer cells also require specific proteins and enzymes. Another family known as MEK inhibitors shows promise. More recently, PD-1 (programmed death) medicines have begun the earliest stages (phase one) study.
Any addition to the melanoma fighting arsenal is greatly welcomed by the oncology community and patients and their families. Yervoy will have an important place in melanoma treatment and also shows promise in a number of other cancers. The medicine carries a high price tag at $120,000 which has generated controversy, yet the benefits in advanced melanoma are unquestionable.
Potential side effects have lead the FDA to include a black box for those with the most concern and they have also required a Risk Evaluation and Mitigation strategy. Regardless, the immune based side effects such as itching (fairly common at roughly 17%) can be managed and others can be helped by corticosteroids. Some blood testing is needed and thyroid function tests and liver function tests should be checked before starting treatment (at baseline) and before each dose.
Clearly, Yervoy offers some much needed lightat what has been a very dark and genetically and biochemically and immunologically complex advanced melanoma tunnel.
Approval Date:
Fri, 03/25/2011
Company:
Bristol-Myers squibb