Roche notches another FDA fast-track review for PD-L1 drug atezolizumab

Roche lab

A month after getting a speedy review for its new immuno-oncology drug atezolizumab in bladder cancer, Swiss major Roche ($RHHBY) has today been given a second fast-track designation for the treatment in certain types of lung cancer.

Specifically, the FDA has granted Roche’s PD-L1 hopeful a priority review for atezolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as a second-line treatment after patients have used a platinum-containing chemotherapy.

The treatment will be part of a personalized approach from Roche as it has also having a Premarket Application (PMA) reviewed by the FDA for its companion immunohistochemistry (IHC) test.

The biomarker diagnostic is set to help identify those patients who express PD-L1, and decide who can best be treated with the drug. The FDA will make a decision in whether to approve atezolizumab in NSCLC on 19 October.

This will be good news for Roche as it comes just a month after the U.S. regulator gave a similar sped up review timeline for the drug in certain bladder cancer patients, which could see it approved by mid-Sept for that license. Analysts are expecting blockbuster sales if the two indications are given in the fall.

Atezolizumab is racing AstraZeneca ($AZN) to be the third of a new class of cancer immunotherapies to gain U.S. approval, behind the leaders Merck ($MRK) and Bristol-Myers Squibb ($BMY) and their offerings Keytruda and Opdivo respectively.  

This now looks like a race it will likely win, given that AstraZeneca’s PD-L1 candidate durvalumab has suffered a series of trial setbacks in recent months, delaying its timeline to market.

But the Anglo-Swedish pharma company has had recent success in the disease, winning a speedy FDA approval for its new NSCLC pill Tagrisso (AZD9291), which is now licensed in the U.S. for NSCLC patients whose tumors express a T790M EGFR mutation. This builds on its ageing lung cancer offering Iressa, which is approved for first-line treatment of EGFR mutation-positive patients with metastatic NSCLC.

But Roche will not be the first to market a new PD-L1 drug in lung cancer as Keytruda has already been approved in the U.S. to treat late-stage NSCLC.

It is fairly far down the treatment pathway however, as it can currently only be used in patients who have tried chemotherapy and tested positive for the EGFR or ALK gene, and also after using an EGFR or ALK inhibitor medicine, such as Iressa or Pfizer’s ($PFE) Xalkori.  

The submission for atezolizumab is based recent data from the open label Phase II BIRCH study, which showed the drug met its primary endpoint of increasing the objective response rate in up to 27% of people whose disease had progressed on prior medicines and also expressed the highest levels of PD-L1.

Another mid-stage study known as Poplar has also showed a statistically significant survival benefit when compared to chemotherapy in patients with recurrent NSCLC whose tumors expressed medium and high levels of PD-L1, which corresponded with people living 7.7 months longer than people who received docetaxel, according to the data.

The Swiss oncology specialist already markets Avastin for patients with a certain genetic mutation as a first-line treatment alongside chemotherapy, but atezolizumab represents its first foray into the new class of check point inhibitor immunotherapies.

- check out Roche’s statement