Spectrum Pharmaceuticals and Zevalin: The Importance of FDA Approval

by: Justin M. Hall

Investors should find the resources in this article helpful to their research efforts on Spectrum Pharmaceuticals regarding Zevalin.

As of March 16, 2009, Zevalin is now manufactured and sold in the US by Spectrum Pharmaceuticals (Nasdaq: SPPI). Zevalin is currently approved as a last resort treatment for refractory NHL. SPPI is seeking approval for Zevalin as a first-line consolidation therapy for NHL. A FDA decision on Zevalin is expected by September 8, 2009.


If Zevalin is approved under the first-line consolidation setting, the drug is more likely to have a better shot at becoming the standard of care for NHL. Some patients, who have received Zevalin or a comparable radioimmunotherapeutic (RIT), Bexxar, would likely argue that Zevalin deserves to be approved and made available for early-stage patients. The current standard of care is Rituxan in combination with chemotherapy. Rituxan is marketed by partners Roche (OTCQX:RHHBY) and Biogen Idec (Nasdaq: BIIB). Bexxar is marketed by GlaxoSmithKline (NYSE: GSK).


Betsy de Parry’s story is one with a happy ending. Betsy is a NHL survivor, one of a few patients in the US who has actually received a RIT for the treatment of her NHL. While Betsy’s story ended positively, more importantly, it exemplifies why patients should be made aware of the Zevalin option. Please make it a point to check out Betsy’s site. Investors should consider purchasing her book, The Roller Coaster Chronicles, which is available for sale on her site.


Video: Zevalin and Bexxar


New York Times article July, 14 2007 which also features Betsy de Parry as well as other NHL survivors.

On July 16, 2007, a blogger responds to the July 14 New York Times article, infra. Here, I found Betsy de Parry’s comments after the article more valuable than the article itself.

New York Times article December 7, 2007 on Medicare reimbursement challenges. SPPI is working with the CMS to correct reimbursement issues. According to a recent presentation at JMP Securities Conference on May 20, 2009, the company appears to be making headway on these issues.

On April 28, 2008, Zevalin was approved in Europe as a first-line consolidation therapy for NHL.

Bexxar versus Zevalin, a factual comparison of the two RITs, Bexxar and Zevalin, approved for refractory NHL at Lymphomation.org


From my view, these resources make the case for Zevalin. Zevalin is an extraordinarily effective treatment for NHL.

Regarding other issues: (1) SPPI is working closely with CMS (Medicare) to alleviate the reimbursement issue which has, in part, led to Zevalin’s disuse. (2) SPPI is also working with the FDA to modify the existing scanning requirements.

If approved under the first-line setting, I believe Zevalin sales will ramp up much faster than other analysts and commentators are expecting. In a recent article, I point out that SPPI’s leadership has the experience and know-how to make it happen for Zevalin. I believe they will.

As some have implied, I do not believe it is responsible to say the pending Zevalin approval will NOT prove to be that important. For patients with NHL, Zevalin’s approval is important. Patients need to be aware of the Zevalin option. Please do NOT take my word for it. Just ask Betsy de Parry. With the first-line approval, I expect more doctors will adopt the treatment and begin treating their patients with it. In time, I anticipate that Zevalin will become the standard of care for NHL in addition to the current treatments. Under this same reasoning, I foresee sales of Zevalin increasing over the next 12-18 months and maybe even beyond.

Here, I think it is appropriate to quote a statement engraved on a paperweight that set atop President Ronald Reagan’s desk throughout the eight years he served in the White House, “It CAN Be Done.”

Zevalin should be made available to early-stage NHL patients.

It’s the right thing to do.

This article is dedicated to my soon to be sister-in-law, Melissa, who was recently diagnosed with cancer one week ago on Friday, July 10, 2009.

Disclosure: Long SPPI