Alembic gets USFDA nod for blood cancer drug: Details here
Alembic Pharmaceuticals just received USFDA approval for its generic version of Dasatinib, a key drug for treating certain types of blood cancer (CML and ALL) in adults, and CML in children.
The USFDA gave the green light this week, and the tablets have been approved in six strengths—so doctors can tailor doses to each patient.
What is dasatinib used for?
Dasatinib is used for people newly diagnosed with Ph+ CML or those who didn't respond well to earlier treatments. It's also approved for kids over one with chronic phase CML.
Alembic's version matches Bristol-Myers Squibb's Sprycel, so patients get the same effect at a lower cost.
US market for dasatinib worth $1 billion
The US market for Dasatinib is worth about $1 billion, according to IQVIA data cited by Alembic, showing how many people need it.
By offering a generic alternative, Alembic may help more patients access vital treatment.
This approval also marks another milestone for Alembic—they've now received 227 ANDA approvals from the USFDA.