An influential group of experts from the FDA has said that small cap Spectrum’s ($SPPI) experimental bladder cancer med Qapzola (apaziquone) isn’t good enough for approval, leaving the treatment’s future hanging in the balance.
The FDA’s advisory committee said Qapzola, which is seeking a license for immediate intravesical instillation post-transurethral resection of bladder tumors, “has not shown substantial evidence of a treatment effect over placebo in patients with non-muscle invasive bladder cancer.”
This is not a final decision and the FDA can decide to go against its committee’s advice, although it typically has followed these in the past. Its PDUFA data is Dec. 11.
The biotech and the FDA have history as in October last year, the regulator rejected its oncology drug, a reformulated take on the chemotherapy melphalan, sold as Alkeran.
But the biotech saw a swift turnaround as in March of this year the FDA allowed the blood cancer med, now known as Evomela, to be sold in the U.S.
Spectrum has also been beset by trial setbacks with Qapzola as back in 2012 two late-stage trials for the med failed to hit their primary endpoints.
The biotech then quickly started a new late-stage study that used input from the FDA and included pooled data from the failed trials. These pooled data, as opposed to those from individual trials, showed a reduction in disease recurrence over two years.
Spectrum fell 8% yesterday on the news, but was up afterhours by nearly 4%, with a market cap just shy of $400 million.