Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘Genentech’

FDA Extends Review Period for Tarceva Application for First-line Maintenance Use in Advanced Non-small Cell Lung Cancer

By on January 15, 2010

Whoa, that was a fascinating news release I saw float through my Twitter stream 2 hours ago:

Picture 87
 

As CNBC's Mike Huckman pointed out, the link appeared Twitter before the press release alert dropped in our inboxes.  Nice one, Genentech!

Anyway, after the very negative ODAC hearing last month where only one panel member voted in favour of approval, it seems that OSI and Roche/Genentech have be granted a reprieve and a chance to address any concerns the FDA may have with the data.

Genentech posted the following statement:

"… the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for Tarceva® (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days. The extension follows OSI's submission of further data in support of the application. The original Prescription Drug User Fee Act (PDUFA) date was January 18, 2010. The companies now anticipate FDA action on the sNDA by April 18, 2010."

It will be interesting to see what information and requests the FDA mandates as the story unfolds, but basically, I think many of us were surprised a complete response was not issued after the extensive roasting at ODAC.  Perhaps there is some meta analysis that will evolve from further subset analysis, time will tell.

Sometimes it's a good to be lucky!

Tarceva maintenance therapy in non-small cell lung cancer

By on December 16, 2009

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.

We posted about the original trial designs earlier this year in February and the initial results from the May ASCO meeting.

More at around 3pm ET today.

{UPDATE: ODAC VOTING 1 YES, 12 NO}


Picture 57

Impact of pazopanib in non-small cell lung cancer (NSCLC)

By on September 23, 2008

At the recent ESMO meeting, GSK's pazopanib, a new oral angiogenesis inhibitor, appeared to show
interesting activity in difficult to treat non-small cell lung cancer (NSCLC). 
The drug is a tyrosine kinase inhibitor that blocks the mechanism by which the protein ensures tumour growth and proliferation, a process known as angiogenesis:

Angiogenesis

Courtesy of Genentech (www.gene.com)

In a phase II trial, 30 out of 35 patients treated with pazopanib preoperatively for a minimum of two weeks saw their tumour size
shrink by up to 85%.  
To date, no other results on the effect of
angiogenesis inhibitors in early stage operable lung cancer have been
published.   Pazopanib indicates that it is a highly
active drug in this setting and further trials are underway in lung cancer.

The researchers felt that the study was novel due to 4 key features:

1) Use of
pre-surgery therapy for early stage lung cancer
2) Use of
targeted monotherapy
3) Use of innovative imaging techniques to
measure exact tumour volume as a 3D object rather than just x and y
measurements
4) Collection of tissue and blood samples
before and after treatment.


Overall, it is hoped that the reduced toxicity of such targeted drugs increases the length of time they can be used and therefore the effectiveness, and ultimately survival, associated with the treatment.  Further trials will be necessary before we know what the long-term potential of this agent is.

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Hot oncology drugs – what's new at ASCO?

By on May 16, 2008

The annual American Society of Clinical Oncology (ASCO) conference begins later this month and the data has just been released.  Here are some key abstracts prior to the presentations:

Eli Lilly’s Alimta (pemetrexed) slowed the spread of non-small cell lung cancer in patients with advanced disease. It’s approved for use in patients who have failed chemotherapy; this study suggests it may be added to treatment earlier in the course of disease.  Lilly are reportedly filing the early data in patients with select histology later this year.  It was recently approved for first-line use in the EU.

Novartis' RAD001 (everolimus/Afinitor); nearly two-thirds of renal cell cancer patients taking had progression of their disease delayed by a year, a significantly better result than in those taking placebo.  The disease did not progress for one year in 65 percent of patients taking RAD001, taken once daily orally, compared to 37 percent in those taking placebo, according to detailed results from a late-stage trial, which was stopped early because it met its main target.

GSK 's Tykerb (lapatinib) demonstrated positive data from the first-ever randomized, multi-center, open label Phase III trial of the combination of two targeted agents, lapatinib and trastuzumab (Herceptin), in women with HER2-positive metastatic breast cancer who had previous been heavily pre-treated with taxanes and anthracyclines.

Genentech's Avastin (bevacizumab) showed improved survival for patients with recurring brain cancer. The Phase II trial compared Avastin with irinotecan chemotherapy to Avastin alone in patients with relapsed glioblastoma multiforme (GBM), the most common and aggressive type of brain cancer.  Median survival was 9.2 months in the Avastin-only arm and 8.7 months in the Avastin and irinotecan arm.  According to historical estimates, only 15 percent of patients with relapsed GBM would be expected to live without their cancer advancing for six months.

ImClone/BMS's Erbitux (cetuximab) new gene findings indicate a simple gene test could allow doctors to predict in advance which patients are likely to benefit from the therapy, ie those without KRAS mutations, since there is evidence that they are more likely to respond to treatment.  The same approach would also apply to Amgen's Vectibix (panitumumab).

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