Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘FDA’

Yesterday was quite day, with one thing and another.  For starters, the FDA ODAC committee finally held a session for Cell Therapeutics pixantrone in 3rd line NHL and ChemGenenex's omacetaxine, for people with the T315i mutation in CML.  The previously scheduled meeting was cancelled due to the Snowpocalyse that hit DC last month. 

I had to dash off to a doctor's appointment myself so missed most of the action on Twitter and rushed back to catch up at lunchtime by checking Twitter buddies such as Kerri Wachter who was live tweeting from the meeting and Adam Feuerstein of The Street's excellent live blog.

This week, (10th February) the FDA's Oncologic Drugs Advisory Committee will be meeting to review the filings from Cell Therapeutics ($CTIC) and ChemGenix ($CXSPY) for pixantrone and omacetaxine, in relapsed refractory NHL and CML, respectively.

I've just taken a few minutes to read the briefing documents and here are my initial thoughts.

Cell Therapeutics, a Seattle based biotech company, are going to have a very tough morning on Wednesday in DC for the following reasons: 

  1. The pivotal study had a very poor accrual with only 140 out of 320 patients enrolled.
  2. Substantial cardiac and hematologic toxicities.

Priority Review designation may be granted by the FDA to an NDA for drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This designation has the potential to expedite the NDA approval process by reducing the target review period for the application from approximately 10 months to six months. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.



Back in February, I took a big picture look at some of the cancer drugs in development that might be reviewed by the FDA for approval in 2009.

You can see the review here.

Of the eight drugs that were highlighted in the post, all were discussed by ODAC, so that was a positive sign.  Five (Afinitor in RCC, Folotyn and Istodax in t-cell lymphomas, pazopanib in RCC and Arzerra in CLL) all passed the final hurdle, receiving a positive FDA opinion, while others (clofarabine, trabectedin and denosumab) were less lucky and issues associated with the filings are still being discussed.  The EU CHMP has issued a positive opinion for Prolia (denosumab) but the FDA seem less convinced so far and issued a complete response letter requesting further information before giving approval.  Amgen seem confident of addressing these issues, so we may well seen a green light soon.


Chomping at the bit, like many others today, to hear how the FDA ODAC meeting goes on regarding Tarceva maintenance therapy in lung cancer.

The initial OSI company presentation appeared to go well, but Q&A session did not; the committee clearly had concerns about the statistics.  The SATURN data in adenocarcinoma was not as impressive as hoped, with the overall survival benefit being one extra month as opposed to taking the drug second line after initial chemotherapy failing and then getting 3 months of extra benefit with either Tarceva or docetaxel.  Sometimes waiting and recovering will get you better results.

Amgen’s recent announcement of phase III trial data showing that it’s monoclonal antibody, denosumab was superior to Novartis’ Zometa (zoledronic acid) for the treatment of breast cancer patients with bone mestastases is further news that scientifically driven drug development can yield exciting results.

Denosumab is in essence a targeted therapy like Gleevec, Avastin or Herceptin.  It’s development came about from basic research that discovered the cellular control of bone remodelling and regulation of bone density is reglated by the RANK Ligand pathway.

This week, Lilly received approval from the U.S. Food and Drug Administration (FDA) for the use of Alimta (pemetrexed), in combination with cisplatin, in the first-line treatment of locally-advanced and metastatic non-small cell lung cancer (NSCLC), for patients with non squamous histology. Alimta is not indicated for treatment of patients with squamous cell non-small cell lung cancer.

According to the American Cancer Society, lung cancer (small cell and non-small cell) is the second most common cancer in both men (after prostate cancer) and women (after breast cancer).  It accounts for about 15% of all new cancers. During 2008, there will be about 215,020 new cases of lung cancer (114,690 among men and 100,330 among women).


The absolute last thing you need when you or a family member is seriously ill with cancer is an illegal scam from snake oil salesmen.

The Federal Trade Commission (FTC)
has charged five companies with making false and misleading claims for
cancer cures and said yesterday that it has reached settlements with several others.  In their press release, the five companies being sued for false and
deceptive advertising will go before administrative law judges and included the following:

Omega Supply

Native Essence Herb Company

Daniel Chapter One


Herbs For Cancer

Yesterday, the FDA blocked the entry of over 30 generic drugs made by India's Ranbaxy due to manufacturing failures. 

"Today's actions are clearly warranted based on the extent
and the seriousness of the violations uncovered during our
inspections of these two sites.  The firm is
sufficiently out of control that we think an import alert should
be put into place until these deficiencies are corrected."

Deborah Autor, Director of the Food and Drug Administration's Drug Compliance Office

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