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The Food and Drug Administration’s review of panobinostat, combined with bortezomib and dexamethasone, for the treatment of multiple myeloma has been extended, the manufacturer has announced.
Novartis Pharmaceuticals submitted the new drug application for the pan-deacetylase (pan-DAC) inhibitor in combination with the proteasome inhibitor bortezomib (Velcade) and dexamethasone for the treatment of patients with previously treated multiple myeloma in March 2104; it was given a priority review of 8 months, instead of the standard 12 months. But the agency has extended the review for up to 3 months, the company said in a Nov. 25 statement.
The FDA was expected to make a decision in November.
“We are committed to working with the FDA as they continue to review” the application, Dr. Alessandro Riva, global head of oncology development and medical affairs at Novartis Oncology, said in the statement.
Panobinostat is an epigenetic regulator, which “may help restore cell programming in multiple myeloma,” and if approved, it would be the first pan-DAC inhibitor approved for treating patients with relapsed or relapsed and refractory multiple myeloma, according to the company.
At a meeting on Nov. 6, the FDA’s Oncologic Drugs Advisory Committee voted 5-2 that the benefits of panobinostat, combined with bortezomib and dexamethasone, did not outweigh the risks for treating patients with multiple myeloma who had received at least one prior therapy, the proposed indication. However, those voting against approval agreed that there was evidence that panobinostat had biologic activity against multiple myeloma and had an effect on progression-free survival, and said they hoped the company would continue to study the drug in patients with the disease.
The Food and Drug Administration’s review of panobinostat, combined with bortezomib and dexamethasone, for the treatment of multiple myeloma has been extended, the manufacturer has announced.
Novartis Pharmaceuticals submitted the new drug application for the pan-deacetylase (pan-DAC) inhibitor in combination with the proteasome inhibitor bortezomib (Velcade) and dexamethasone for the treatment of patients with previously treated multiple myeloma in March 2104; it was given a priority review of 8 months, instead of the standard 12 months. But the agency has extended the review for up to 3 months, the company said in a Nov. 25 statement.
The FDA was expected to make a decision in November.
“We are committed to working with the FDA as they continue to review” the application, Dr. Alessandro Riva, global head of oncology development and medical affairs at Novartis Oncology, said in the statement.
Panobinostat is an epigenetic regulator, which “may help restore cell programming in multiple myeloma,” and if approved, it would be the first pan-DAC inhibitor approved for treating patients with relapsed or relapsed and refractory multiple myeloma, according to the company.
At a meeting on Nov. 6, the FDA’s Oncologic Drugs Advisory Committee voted 5-2 that the benefits of panobinostat, combined with bortezomib and dexamethasone, did not outweigh the risks for treating patients with multiple myeloma who had received at least one prior therapy, the proposed indication. However, those voting against approval agreed that there was evidence that panobinostat had biologic activity against multiple myeloma and had an effect on progression-free survival, and said they hoped the company would continue to study the drug in patients with the disease.
The Food and Drug Administration’s review of panobinostat, combined with bortezomib and dexamethasone, for the treatment of multiple myeloma has been extended, the manufacturer has announced.
Novartis Pharmaceuticals submitted the new drug application for the pan-deacetylase (pan-DAC) inhibitor in combination with the proteasome inhibitor bortezomib (Velcade) and dexamethasone for the treatment of patients with previously treated multiple myeloma in March 2104; it was given a priority review of 8 months, instead of the standard 12 months. But the agency has extended the review for up to 3 months, the company said in a Nov. 25 statement.
The FDA was expected to make a decision in November.
“We are committed to working with the FDA as they continue to review” the application, Dr. Alessandro Riva, global head of oncology development and medical affairs at Novartis Oncology, said in the statement.
Panobinostat is an epigenetic regulator, which “may help restore cell programming in multiple myeloma,” and if approved, it would be the first pan-DAC inhibitor approved for treating patients with relapsed or relapsed and refractory multiple myeloma, according to the company.
At a meeting on Nov. 6, the FDA’s Oncologic Drugs Advisory Committee voted 5-2 that the benefits of panobinostat, combined with bortezomib and dexamethasone, did not outweigh the risks for treating patients with multiple myeloma who had received at least one prior therapy, the proposed indication. However, those voting against approval agreed that there was evidence that panobinostat had biologic activity against multiple myeloma and had an effect on progression-free survival, and said they hoped the company would continue to study the drug in patients with the disease.
