3 Things In Biotech You Should Learn Today: July 13, 2017

Jul. 13, 2017 9:30 AM ETLLY, NVS, PFE5 Comments
Zach Hartman profile picture
Zach Hartman


  • Pfizer gets the nod despite safety concerns in AML.
  • Groundbreaking CAR-T cell ODAC thumbs-up.
  • Lilly's newest breast cancer drug gets priority review.

Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep up with the news in biotech and pharmaceutical research.

And today's a big day with the FDA! Let's get to it.

Pfizer gets the nod despite safety concerns in AML

On July 11, Pfizer (PFE) faced a big oncology drug advisory committee (ODAC) meeting to discuss the fate of its antibody-drug conjugate gemtuzumab ozogamicin for treatment of patients with AML.

As of a few days ago, it seemed that there were some serious outstanding questions relating to the toxicity of this agent, with an increased level of severe liver toxicity casting some doubt on the future of gemtuzumab.

The ODAC agreed on a 6 to 1 vote that a revised "fractionated" dosing scheme sufficiently reduced the tolerability concerns for this agent. Moreover, the event-free survival observed in clinical trials was deemed meaningful.

So the scientists have now weighed in, and gemtuzumab ozogamicin is a go. The final FDA decision is expected in September.

Looking forward: This is definitely good news for PFE and for patients with AML, as 2017 has proven to be a banner year for treatment of this difficult form of leukemia. The lone dissenter indicated that he would have liked for treatment to be restricted to patients with favorable or intermediate-risk cytogenetics, but the panel ultimately decided that this should be a decision left up to patients and their doctors.

Groundbreaking CAR-T cell ODAC thumbs-up

Recently we covered the briefing document that Novartis (NVS) received for CTL019 in acute lymphoblastic leukemia, which highlighted some areas of concern that NVS would be asked to discuss with the oncology drug advisory committee.

Specifically, safety and manufacturing concerns had an outside shot at threatening the approval of CAR-T cells.

This article was written by

Zach Hartman profile picture
I am a former PhD scientist-turned-writer focused on cancer education. My writings in Seeking Alpha have been devoted to helping people identify promising investment opportunities in cancer research through commentary of recent events. Readers can learn more about other aspects of cancer research by visiting my site Invest Against Cancer.I also collaborate with Avisol Capital Partners on their Marketplace service known as the Total Pharma Tracker (TPT). Some of my work will be available to TPT subscribers either exclusively, or in advance. If you are interested, please click the link above!

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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