- The US FDA published the warning letter on October 27, 2021, just 2 days before CMC Type A meeting with Sesen Bio. The move informed its rejection of the BLA.
- Ahead of the Type A meeting, the burden of proof will be on Sesen’s side to show the efficacy of Vicineum post-2017.
- Sesen Bio is gearing towards product commercialization with strategic hires into 2022.
- Study shows that high-prescribing urologists would use a treatment agent branded with Vicineum in more than 80% of the BCG-unresponsive NMIBC patients as opposed to 17% with Keytruda.
- Sesen Bio is able to fund its capital operations including R&D until 2023 when it is expected to begin commercialization of Vicineum.
For further details see:
Sesen Bio: Hoping For An Easy Revalidation Of Vicineum By 2022