Roche ($RHHBY), the world's biggest oncology drugmaker, is set to have its new bladder cancer treatment atezolizumab approved by this fall as the FDA green-lights a speedy review.
The Swiss company said in a statement that the U.S. regulator has accepted the company's biologics license application and granted priority review for atezolizumab in certain patients with a late-stage form of the disease. The drug was given breakthrough therapy status by the FDA back in 2014.
Specifically, Roche is seeking a license for the treatment of patients with locally advanced or metastatic urothelial carcinoma who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within a year of receiving platinum-based chemotherapy before surgery or after surgery.
Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.
There are currently few drug options for treating bladder cancer outside of chemotherapy--although a number of drugs from Novartis ($NVS), Merck ($MRK) and Allergan ($AGN) are also looking to get in on this burgeoning new market.
A priority review is usually given by the FDA when a new drug treats a disease with few options, or is particularly effective. It speeds up its marketing review to just 6 months--meaning the FDA will make a decision on approval by Sept. 12.
Roche's most recent study for the drug--the Phase II, open-label IMvigor 210 trial--found that after 11.7 months of median follow-up, atezolizumab shrank tumors in 15% of the 310 patients tested whose disease progressed after platinum-based chemotherapy.
Atezolizumab also shrank tumors in 26% of 100 patients whose disease had medium and high levels of PD-L1 expression. The drug was originally developed by Roche's Californian biotech arm Genentech.
Roche is looking to be the first company to bring an anti-PD-L1 immunotherapy to the market for this particular cancer.
It is however playing catch-up in the PD-1 (programmed death-1) and PD-L1 (programmed death ligand-1) market race, as rivals Bristol-Myers Squibb ($BMY) and Merck have already gained approval for their PD-1 medicines Opdivo and Keytruda, which both received the FDA nod for melanoma in 2014.
Roche is also battling with AstraZeneca ($AZN) to be the third to market in this new therapy area--although its PD-L1 drug works slightly differently to the approved PD-1 medicines on the market. Atezolizumab directly binds to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors.
The Swiss major is betting that its mechanism of action will help separate it from the PD-1 field, and also lead to better cure rates in the long term.
Merck is however also testing Keytruda in certain bladder cancer patients who exhibit PD-L1 biomarkers--meaning Roche could have an immediate competitor should both drugs gain approval.
More than around 76,000 Americans will be diagnosed with bladder cancer in 2016, and about 11% of new diagnoses are made when bladder cancer is in advanced stages.
The PD-1 and PD-L1 market is set to be worth around $30 billion by the end of the decade, although Bristol-Myers is expected to take around a $6 billion share of this as Opdivo is set to gain further cancer licenses in the coming years.
Atezolizumab is also being studied in a Phase I trial in combination with Amgen's ($AMGN) cancer immunotherapy Imlygic in patients with triple-negative breast cancer and colorectal cancer with liver metastases. It's also posted survival data among patients with non-small cell lung cancer who express high levels of PD-L1, as well as starting new trials into assessing its efficacy in certain kidney cancer patients.
Roche will hope for this to become a blockbuster treatment and help shore up sales in the next decade, given that a slew of copycat biosimilars are set to erode sales of its big-selling oncology products Avastin and Rituxan.
- read the statement