Spectrum (SPPI) Gets CRL For Bladder Cancer Drug In U.S.
Zacks Investment Research | Nov 21, 2016 07:24AM ET
Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) announced that it has received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Qapzola (apaziquone).
The company was looking to get Qapzola approved for the immediate intravesical instillation, post transurethral resection of bladder tumors (post-TURBT) in patients with non-muscle invasive bladder cancer (NMIBC).
Consequently, Spectrum has stopped enrolling patients in the ongoing phase III program on Qapzola and is currently conducting a new smaller study on the candidate, following discussions with the FDA.
Note that this September, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against the approval of Qapzola. The ODAC stated that Qapzola failed to demonstrate a substantial evidence of a treatment effect in comparison with placebo.
We remind investors that Spectrum reacquired global development and commercialization rights to Qapzola in the U.S., Europe and other territories from Allergan plc (NYSE:AGN) under an amended collaboration agreement in 2013.
The unfavorable response from the FDA is highly disappointing. Considering the lack of FDA-approved treatments for post-TURBT instillation in patients with NMIBC, there exists significant unmet for new treatment options.
Although Spectrum’s product portfolio currently comprises six marketed products, the company has been unable to generate substantial revenues for most of them. Therefore, approval of pipeline candidates is crucial for the company.
Encouragingly though, Spectrum’s shares were unaffected by the announcement.
Going forward, investor focus is expected to remain on further updates by the company on Qapzola.
SPECTRUM PHARMA Price
Original post
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.