Global Demand for Bladder Cancer Treatment Threatens Supply in 2019
For the US and many other countries, Merck is the sole supplier of BCG Live (intravesical)
Due to an increase in global demand, TICE BCG, (Bacillus of Calmette and Guerin [BCG] strain of Mycobacterium bovis live, attenuated culture preparation; Merck) is expected to be in short supply in 2019, according to information provided by the manufacturer to the Food and Drug Administration (FDA).
TICE BCG is indicated for the treatment and prophylaxis of carcinoma in situ of the urinary bladder and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection. While the product is currently available, the Company expects that supply constraints could occur this year and may require it to be placed on allocation once demand exceed production plans. For the US and many other countries, Merck is the sole supplier of BCG Live (intravesical).
TICE BCG is supplied in a vial that contains 1 to 8 x 108 CFU, which is equivalent to approximately 50mg (wet weight), as lyophilized (freeze-dried) powder. The treatment is administered intravesically following reconstitution.
For more information visit FDA.gov.