The FDA approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses the patient’s own immune system to fight the disease. Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment. The majority of adverse reactions with Provenge were mild or moderate in severity. (April 29, 2010)
The FDA approved erlotinib (Tarceva) tablets for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after 4 cycles of platinum-based first-line chemotherapy. This approval is erlotinib’s second indication in locally advanced or metastatic NSCLC. Erlotinib was originally approved in November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least 1 prior chemotherapy regimen. (April 16, 2010)
The FDA approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product used to improve food digestion in patients whose bodies do not produce enough pancreatic enzymes. This includes people who have conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas. (April 12, 2010)
The FDA has been informed by Lundbeck Inc, the sole worldwide manufacturer of Mustargen (mechlorethamine HCl for injection), that an extended supply shortage of this drug is in the offing.
A limited supply of Mustargen is expected to be available starting in mid-to-late April, and will be distributed by Lundbeck Inc to meet current patient needs, with priority given to sites with patients currently receiving Mustargen. Once this limited supply is exhausted, a shortage is anticipated until early 2011. Given the expected shortage, alternative treatment plans should be made for new patients to avoid interruption to a Mustargen treatment program. (April 9, 2010)
The FDA approved a new formulation of the controlled-release drug OxyContin that is designed to discourage misuse and abuse of the medication. The reworked capsule is intended to prevent the medication from being cut, broken, chewed, crushed, or dissolved to release medication more quickly. The drug’s manufacturer, Purdue Pharma, LP, will be required to conduct a postmarket study to evaluate the effectiveness of the new formulation in lessening abuse, as well as a risk evaluation and mitigation strategy. (April 5, 2010)
