The US Food and Drug Administration (FDA)
approved ipilimumab for late - stage melanoma in 2011.
Since
approving ipilimumab five years ago, the Food and Drug Administration has OK'd two similar drugs — pembrolizumab and nivolumab — for melanoma and certain lung cancers.
Not exact matches
My apology comes with a small caveat, which is that
ipilimumab (or Yervoy, as it has been branded) was not
approved for prostate cancer.
BMS's drug,
ipilimumab (Yervoy), was the first checkpoint inhibitor (a kind of cancer immunotherapy drug that essentially helps the immune system release its brake and go after tumor cells it might normally miss) to get
approved in the US in 2011 for melanoma.
In December 2014 the FDA
approved Opdivo (nivolumab), which, like
ipilimumab, is another checkpoint inhibitor to treat melanoma.
The next year, the FDA
approved another immunotherapy agent,
ipilimumab, to treat melanoma.
As reported in 2015, the study met its primary endpoint after a median follow up of 2.3 years, with
ipilimumab significantly improving recurrence - free survival.2 The drug was subsequently
approved by the US Food and Drug Administration as adjuvant therapy for stage III melanoma.
They studied the effects of this treatment in combination with
ipilimumab, a U.S. Food and Drug Administration -
approved immunotherapy.
The first of these drugs,
ipilimumab (Yervoy ®) was
approved by federal regulators to treat advanced melanoma.
The multicenter trial involving 100 patients showed that the addition of
ipilimumab to nivolumab, which is currently FDA -
approved for treatment of kidney cancer, leads to responses that can last beyond two years.
Combination immunotherapy with nivolumab and
ipilimumab as tested in the kidney cancer study described here is already FDA -
approved for treatment of melanoma, and is being tested for other cancers.
The new studies find high activity with investigative drugs for advanced melanoma, and show for the first time that
ipilimumab, a treatment already
approved for advanced melanoma, can substantially decrease the risk of melanoma recurrence in certain patients with earlier - stage disease.
FDA
approves the anti-CTLA-4 monoclonal antibody
ipilimumab (Yervoy) for the treatment of metastatic melanoma.
And again, that is an immunologic drug, and it was
approved on the basis of prolonged relapse - free survival — that is, prolonged time to return of the tumor compared with
ipilimumab, which as I mentioned was the standard since 2015.
Last year the Food and Drug Administration
approved Benlysta (belimumab), the first new treatment for systemic lupus erythematosus in more than 50 years, and Yervoy (
ipilimumab), the first drug shown to prolong the lives of patients with melanoma.
Ipilimumab is currently the US Food and Drug Administration (FDA)-
approved standard of care treatment for resected stage III melanoma in the United States.
Dr. Wolchok has been at the forefront of cancer immunotherapy and is renowned for leading the clinical trials that led to the first FDA -
approved checkpoint inhibitor immunotherapy, the anti-CTLA-4 antibody
ipilimumab.
Perhaps most promising are results from a combination treatment using both
ipilimumab and nivolumab, which the FDA
approved in 2015 for previously untreated (first - line) unresectable or metastatic melanoma for patients without a BRAF mutation.
In 2011,
ipilimumab (Yervoy)-- which targets the CTLA - 4 pathway — was
approved by the FDA to treat unresectable or metastatic melanoma.
The immune - based treatment Yervoy (
ipilimumab) was the first drug shown to extend survival among patients with advanced melanoma and was
approved by the FDA in 2011.
As a single agent,
ipilimumab is
approved as a second - line treatment, as well as adjuvant therapy for patients with completely resected melanoma.
A head - to - head comparison of nivolumab and
ipilimumab, both FDA -
approved medications for metastatic melanoma, was conducted with 906 patients with high - risk stage IIIb, IIIc, and IV melanoma.
Ipilimumab is the second active immunotherapy for cancer to be
approved by the FDA, following the approval in April 2010 of sipuleucel - T (Provenge ®) for advanced castrate - resistant prostate cancer.
The first drug of this kind was the anti-CTLA-4 antibody called
ipilimumab, which is manufactured by Bristol - Myers Squibb and which the FDA
approved in 2011.
In the spring of 2011, the FDA
approved the immunotherapy treatment
ipilimumab, known by the brand name Yervoy.