Cancer drug developers angling for center stage at ASCO

Posted under Ariad Pharmaceuticals, ArQule, Array BioPharma, ASCO, axitinib, Blog, breast cancer, cabozantinib, Cancer, Cancer Drugs, Companies, Diagnostics, Eli Lilly, Exelixis, Funding, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Pipeline, renal cell carcinoma, Roche, Startups, Universities, Videos by john

Later this week the cancer drug research crowd will examine a tsunami of abstracts filed ahead of the ASCO meeting in early June in the hopes of finding a few new gems in the mountain of data being readied for the confab. ASCO is the place where anyone who's doing anything in cancer tries to make a splash in the spotlight. And with close to a thousand cancer drugs in the pipeline, that's no easy task.

Pfizer ($PFE) and Eli Lilly ($LLY) were both out bright and early this morning touting their work in the cancer arena. Pfizer's best hope at drawing attention lies in updating the data on axitinib, its recently approved treatment for renal cell carcinoma. And Lilly clearly hopes to impress analysts with ramucirumab, which is in 6 late-stage cancer studies.

Digging deeper, Executive Editor Ryan McBride's recent take on the top 10 cancer drugs in late-stage studies includes some of the closest watched therapies likely to elbow their way to center stage. Aveo ($AVEO) will be working hard to distinguish tivozanib--its kidney cancer drug with so-so head-to-head data with Nexavar--as it takes a monumentally important run at an approval later this year. Anything new on Roche's ($RHHBY) T-DM1 for breast cancer, which has racked up positive late-stage data on breast cancer on its way to an odds-on approval at the FDA, will be studied closely. Onyx ($ONXX) has the promising carfilzomib to tout, which is already at the FDA for review, while regorafenib (majority-owned by Bayer) is also in the media mix.

Today in Xconomy, the savvy biotech scribe Luke Timmerman assesses 8 drugs likely to make it into the center ring at ASCO. In addition to the drugs already mentioned, Timmerman includes abiraterone (Zytiga) from J&J ($JNJ) and Exelixis's ($EXEL) cabozantinib, a promising cancer drug that has earned Exelixis CEO Mike Morrissey both acclaim and exceptionally harsh criticism. The development program for cabo has been raked over the coals by a number of analysts. Medivation's enzalutamide (MDV3100), meanwhile, could wind up stealing the thunder for prostate cancer. And there's follow-up data from Ariad ($ARIA) on ponatinib.

Back in mid-March Adam Feuerstein at TheStreet got the first crack at an ASCO preview, listing prospects from Celldex, ArQule, Array BioPharma and Oncothyreon among the more frequently mentioned drug developers. But Celldex's ($CLDX) CDX-011 presentation was scrapped due to a clerical error. Now Celldex is planning a preemptive strike, with plans to hold a press conference of its own on May 23.

If you can't join them at ASCO, you can always try to beat them to the punch.

- here's the story from Xconomy
- read Adam Feuerstein's piece in TheStreet

Special Report: Top 10 Late-Stage Cancer Drugs - 2012

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Pfizer nails unanimous expert panel vote for kidney cancer drug

Posted under axitinib, Blog, Companies, Diagnostics, Funding, Inlyta, Medical Devices, Medical Supply, Nexavar, Pfizer, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Pfizer's ($PFE) cancer drug team nailed a unanimous endorsement from an FDA expert panel this morning following its review of axitinib, setting it on a path to a likely approval for patients with advanced kidney cancer.  The experts formally concluded that the drug's benefits justified the risks it posed to patients.

That winning vote represents a small but important step for Pfizer, which stands to earn more than a half billion dollars a year from the drug if it goes on to an approval. While not a blockbuster, the drug represents at least a partial response to the loss of the Lipitor franchise. In recent years Pfizer had earned a reputation as the poster child for clinical stage failures, suffering through a series of embarrassing setbacks. But recently it's shown signs of becoming more effective at developing new drugs. Pfizer plans to sell axitinib as Inlyta.

Some of the experts who voted in favor of the drug noted that axitinib compared favorably with Nexavar. But with data supporting only two months of added progression-free survival, not all the experts were impressed. The Wall Street Journal noted that one of the panelists observed that the drug is "not a touchdown, and maybe not even a first down," but warranted approval.

Analysts have also been paying close attention to AVEO's rival kidney cancer drug, tivozanib, one of the most promising cancer drugs now in late-stage studies.

- read the report from The Wall Street Journal
- get the story from Bloomberg

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