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The Food and Drug Administration has approved talimogene laherparepvec (T-VEC), an oncolytic immunotherapy, for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that has recurred after initial surgery, the manufacturer Amgen announced today.
The approval officially makes T-VEC (Imlygic) the first virus-based cancer treatment ever approved, as it is derived from the herpes simplex virus. The FDA’s approval comes just months after an FDA advisory panel voiced their support for T-VEC’s approval in a 22-1 vote, based on a phase III study published in the Journal of Clinical Oncology (2015;33 [25]2780-8).
The study looked at 436 individuals with either stage IIIB/C or stage IV (with limited visceral disease burden considered unresectable) and found that patients treated with T-VEC had a significantly higher overall response rate (26.4%) and complete response rate (10.8%) than did those who were treated with subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF) (5.7% and 0.7%, respectively).
The durable response rate was also significantly higher among T-VEC–treated patients (16.3%) than among those on GM-CSF (2.1%). T-VEC patients also experienced a median overall survival time of 23.3 months, compared with 18.9 months for those on GM-CSF. In the study, cellulitis was noted in about 2% of patients on T-VEC. Fifty-four percent of T-VEC patients who responded to the treatment initially had disease progression before response began.
“The evidence of local and systemic immune responses with T-VEC supports combinations with other immunotherapies as a rational approach. A phase 1b/2 study of T-VEC and ipilimumab is evaluating the safety and efficacy of this combination,” wrote the investigators of the phase III study, which was led by Dr. Robert Andtbacka of the Huntsman Cancer Institute at the University of Utah, Salt Lake City.
T-VEC was also scrutinized in five other studies, all of which reported that the most common adverse events related to the drug were fatigue, chills, and pyrexia and flulike symptoms; severity of these symptoms ranged from mild to moderate.
The manufacturer intends to make the therapy available to patients almost immediately and anticipates its cost to average $65,000, according to a statement.
The Food and Drug Administration has approved talimogene laherparepvec (T-VEC), an oncolytic immunotherapy, for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that has recurred after initial surgery, the manufacturer Amgen announced today.
The approval officially makes T-VEC (Imlygic) the first virus-based cancer treatment ever approved, as it is derived from the herpes simplex virus. The FDA’s approval comes just months after an FDA advisory panel voiced their support for T-VEC’s approval in a 22-1 vote, based on a phase III study published in the Journal of Clinical Oncology (2015;33 [25]2780-8).
The study looked at 436 individuals with either stage IIIB/C or stage IV (with limited visceral disease burden considered unresectable) and found that patients treated with T-VEC had a significantly higher overall response rate (26.4%) and complete response rate (10.8%) than did those who were treated with subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF) (5.7% and 0.7%, respectively).
The durable response rate was also significantly higher among T-VEC–treated patients (16.3%) than among those on GM-CSF (2.1%). T-VEC patients also experienced a median overall survival time of 23.3 months, compared with 18.9 months for those on GM-CSF. In the study, cellulitis was noted in about 2% of patients on T-VEC. Fifty-four percent of T-VEC patients who responded to the treatment initially had disease progression before response began.
“The evidence of local and systemic immune responses with T-VEC supports combinations with other immunotherapies as a rational approach. A phase 1b/2 study of T-VEC and ipilimumab is evaluating the safety and efficacy of this combination,” wrote the investigators of the phase III study, which was led by Dr. Robert Andtbacka of the Huntsman Cancer Institute at the University of Utah, Salt Lake City.
T-VEC was also scrutinized in five other studies, all of which reported that the most common adverse events related to the drug were fatigue, chills, and pyrexia and flulike symptoms; severity of these symptoms ranged from mild to moderate.
The manufacturer intends to make the therapy available to patients almost immediately and anticipates its cost to average $65,000, according to a statement.
The Food and Drug Administration has approved talimogene laherparepvec (T-VEC), an oncolytic immunotherapy, for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that has recurred after initial surgery, the manufacturer Amgen announced today.
The approval officially makes T-VEC (Imlygic) the first virus-based cancer treatment ever approved, as it is derived from the herpes simplex virus. The FDA’s approval comes just months after an FDA advisory panel voiced their support for T-VEC’s approval in a 22-1 vote, based on a phase III study published in the Journal of Clinical Oncology (2015;33 [25]2780-8).
The study looked at 436 individuals with either stage IIIB/C or stage IV (with limited visceral disease burden considered unresectable) and found that patients treated with T-VEC had a significantly higher overall response rate (26.4%) and complete response rate (10.8%) than did those who were treated with subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF) (5.7% and 0.7%, respectively).
The durable response rate was also significantly higher among T-VEC–treated patients (16.3%) than among those on GM-CSF (2.1%). T-VEC patients also experienced a median overall survival time of 23.3 months, compared with 18.9 months for those on GM-CSF. In the study, cellulitis was noted in about 2% of patients on T-VEC. Fifty-four percent of T-VEC patients who responded to the treatment initially had disease progression before response began.
“The evidence of local and systemic immune responses with T-VEC supports combinations with other immunotherapies as a rational approach. A phase 1b/2 study of T-VEC and ipilimumab is evaluating the safety and efficacy of this combination,” wrote the investigators of the phase III study, which was led by Dr. Robert Andtbacka of the Huntsman Cancer Institute at the University of Utah, Salt Lake City.
T-VEC was also scrutinized in five other studies, all of which reported that the most common adverse events related to the drug were fatigue, chills, and pyrexia and flulike symptoms; severity of these symptoms ranged from mild to moderate.
The manufacturer intends to make the therapy available to patients almost immediately and anticipates its cost to average $65,000, according to a statement.
FROM THE FDA
