Back to top

Pfizer's Xalkori Gets Breakthrough Status for New Indications

Read MoreHide Full Article

Pfizer Inc. (PFE - Free Report) announced that the FDA granted Breakthrough Therapy designation to its lung cancer drug, Xalkori (crizotinib) for two new indications.

Xalkori is already marketed for the treatment of ALK+ or ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). In-fact, it is only FDA-approved treatment indicated for both ALK-positive and ROS1-positive metastatic NSCLC.

The FDA granted Breakthrough Therapy designation to Xalkori for the treatment of patients with metastatic NSCLC with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The designation for this indication was supported by results from an expansion cohort of the phase I PROFILE 1001 study, in which Xalkori showed antitumor activity.

Another indication for which Breakthrough Therapy designation was granted to Xalkori was for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALKpositive. The designation for this indication was supported by two studies — Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588).  The studies showed compelling antitumor activity in pediatric and adult patients treated with Xalkori.

The designation from the FDA is intended to expedite the development and review of drugs with early evidence of substantial potential clinical benefit to patients.

Shares of Pfizer have declined 1.5% year to date, compared with the industry’s decline of 6%.


NSCLC is a difficult-to-treat disease, accounting for about 85% of lung cancer cases. At present, the lung cancer treatment market is highly crowded with drugs like Bristol-Myers Squibb’s (BMY - Free Report) Opdivo, Merck’s (MRK - Free Report) Keytruda, Roche’s (RHHBY - Free Report) Alecensa, Novartis’ Zykadia and Taxotere among others.

Zacks Rank

Pfizer has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.


Today's Stocks from Zacks' Hottest Strategies

It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.

And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.

See Them Free>>

More from Zacks Analyst Blog

You May Like