Johnson & Johnson says that an application to get expanded approval for its prostate cancer drug Zytiga has been given a priority review by regulates in the USA.
The US Food and Drug Administration has decided to take a quicker look at the supplemental New Drug Application for Zytiga (abiraterone) administered in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The filing specifically refers to patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.
Getting priority review, which is granted to drugs, that may offer major advances in treatment, or provide an option where no adequate therapy exists. means that a decision on Zytiga in this indication will be made in six months. Normally an FDA review takes 10-12 months.
The sNDA, which was submitted in June, is based on impressive progression-free survival Phase III data presented at the American Society of Clinical Oncology this year. Zytiga was approved in the USA last April for the treatment of patients with mCRPC who have received prior chemotherapy containing docetaxel.
Fresh OK for Nucynta
Meantime, J&J has received FDA approval to expand use of Nucynta ER (extended-release tapentadol.
The painkiller, which is already approved for extended use in moderate to severe chronic pain, is now the only opiod approved for the management of neuropathic pain associated with diabetic peripheral neuropathy. DPN is estimated to affect nearly eight million Americans.
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