The other shoe has dropped at Aveo Oncology. Days after the Cambridge, MA-based biotech whacked close to two-thirds of its staff as it scrambled to stay afloat in the wake of a scathing regulatory assessment of its lead drug, the developer says that the FDA has handed over the expected rejection notice for tivozanib as a treatment for kidney cancer.
Aveo ($AVEO) says that the complete response letter from the FDA concluded that the "inconsistent progression-free survival and overall survival results and imbalance in post-study treatments make the TIVO-1 results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval." To get an approval, the FDA noted, Aveo would have to mount another trial for renal cell carcinoma.
That RCC trial, though, won't be happening. After Aveo insisted for months that it had the data needed to win an approval, the FDA panel review--featuring a brutal critique of the Phase III program by agency oncology chief Richard Pazdur--forced partner Astellas Pharma to drop any support on RCC. After the company stock price disintegrated, Aveo decided to restructure, laying off 140 staffers and focusing on ongoing trials for other cancer indications.
Aveo said last week that its restructuring had extended the biotech's cash runway by two years. And it will need extra time and some clearly positive trial results to make up for a legendary critique of its work. This time around, though, the company will not have much leeway when it comes to explaining either progression-free survival, overall survival or the design of its clinical trials. With the entire management team under CEO Tuan Ha-Ngoc left largely intact, with the exception of a departing COO, the company faces a hefty deficit of trust with investors and analysts.
- here's the press release