Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘Genentech’

FDA approves Roche hedgehog inhibitor vismodegib/Erivedge in basal cell carcinoma

By on January 30, 2012

It’s been quite a roller coaster ride for Hedgehog inhibitors of late.

infinity logo FDA approves Roche hedgehog inhibitor vismodegib/Erivedge in basal cell carcinomaLast week, brought negative data as Infinity announced that their phase II trial with saridegib (IPI-926) had been stopped for futility in pancreatic cancer.  This trial sought to determine the impact of the hedgehog in combination with gemcitabine over gemcitabine alone in advanced pancreatic cancer.  Unfortunately, the trial was stopped for futility, meaning the control arm was doing better than the treatment arm.

This is a preview of FDA approves Roche hedgehog inhibitor vismodegib/Erivedge in basal cell carcinoma. Read the full post

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A new opportunity for vemurafenib in BRAFV600E colon cancer

By on January 26, 2012

There’s been quite a flurry of commercial news on the Pharma front this morning, with Amgen buying Micromet (whose leading product is blinatumumab in ALL) and Celgene announcing their acquisition of Avila Therapeutics who have a Bruton Kinase Inhibitor (BTK) AVL-292 in phase IB development for lymphomas, which was all the rage at the recent American Society of Hematology (ASH) meeting last month.

The big news for me today, though, wasn’t the commercial acquisitions but a gem of a paper relating to science and its significance for future cancer treatment.

This is a preview of A new opportunity for vemurafenib in BRAFV600E colon cancer. Read the full post

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Roche files vismodegib for basal cell carcinoma with FDA

By on September 12, 2011

Good news this morning as Roche announced that their Hedgehog (Hh) inhibitor licensed from Curis, GDC-0449 (now known as vismodegib), has been submitted to the FDA for the treatment of advanced basal cell carcinoma (BCC) in patients for whom surgery is not appropriate.

The filing is based on phase II data from the ERIVANCE (BCC/SHH4476g) phase II trial that was reported earlier this year at the American Association of Cancer Research (AACR) meeting. The pivotal trial was a single arm study with the design based on discussions with the FDA, since there are no approved therapies for this setting. In other words, these are refractory patients with advanced disease.

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ODAC votes unanimously against Genentech and Avastin in metastatic breast cancer

By on June 29, 2011

Finally, we have a result from the public hearing in Washington DC on whether Avastin is a safe and effective drug in first line treatment of metastatic breast cancer after the Oncology Drugs Advisory Committee (ODAC) voted 6-0 against on all three questions (was Avastin effective, safe and should the indication continue to be upheld).

An overwhelming victory for CDER’s case rather than Genentech/Roche’s.

For those of you wondering whether there was any wriggle room for manoeuvre, take a look at the data for yourselves from the original ODAC meeting last year when the FDA reviewed it.  I put together the response rates and survival curves from the RIBBON1 and AVADO trials at the time, based on the publicly available data on the FDA site for all to see.

This is a preview of ODAC votes unanimously against Genentech and Avastin in metastatic breast cancer. Read the full post

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Crossing the blood brain barrier with drug development

By on May 26, 2011

The beauty of social media is that sometimes someone shares something monumental before you even pick it up yourself in a journal you’re subscribed to. I love that – it’s a great way to see how others find things with what I call ‘interestingness’.  This morning, John Carroll of Fierce Biotech tweeted something that gave me goosebumps.

What was hot this morning you may all be wondering?

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Antibody Drug Conjugates (ADCs) in cancer research: what are they?

By on May 25, 2011

Quite a few questions have hit my inbox recently from people wanting to know more about Antibody Drug Conjugates (ADCs) and how they work.

They basically consist of three things:

  1. Monoclonal antibody
  2. Linker
  3. Cytotoxic agent

Picture 39 Antibody Drug Conjugates (ADCs) in cancer research: what are they?

Source: Roche

The goal is to create a new molecule that essentially is greater than the sum of its parts by making it more targeted, like a guided missile against the cancer cells.

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Roche files vemurafenib for metastatic melanoma in Europe and US

By on May 12, 2011

Yesterday, Roche/Genentech announced that they have submitted the New Drug Application (NDA) filing for PLX4032 (vemurafenib) in BRAF V600E mutation-positive metastatic melanoma, based on BRIM2 and BRIM3 trials to both the FDA and EMA.

I’ve posted quite a bit on BRAF inhibitors such as vemurafenib on this blog – check out the related posts feature at the bottom if you want to learn more about the history of this class of drugs.

Interestingly, Roche have also submitted the companion diagnostic, cobas 4800 BRAF V600 Mutation Test, which means that oncologists in the community will be able to more easily test patients for the mutation, since these patients are more likely to respond to therapy with BRAF inhibitors such as vemurafenib.

This is a preview of Roche files vemurafenib for metastatic melanoma in Europe and US. Read the full post

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FDA moves to withdraw Avastin in breast cancer

By on December 16, 2010

Well, the long awaited decision by the FDA on bevacizumab (Avastin) in breast cancer has finally been published and is probably the least surprising decision by the agency in 2010:

“The Office of New Drugs (OND) recommends withdrawing approval of the breast cancer indication for bevacizumab (Avastin).  This indication was approved on February 22, 2008, under accelerated approval provisions for use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer.

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FDA rejects the Roche Immunogen T-DM1 accelerated approval filing

By on August 27, 2010

Interesting news arrived in my email box this morning:

"Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the company’s trastuzumab-DM1 (T-DM1) Biologics License Application (BLA). As planned Roche will continue with its ongoing Phase III EMILIA registration study. Roche will continue to work with the FDA and expects a global regulatory submission of T-DM1 mid 2012.

This is a preview of FDA rejects the Roche Immunogen T-DM1 accelerated approval filing. Read the full post

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Somatic mutations and pathway alterations in cancer

By on August 5, 2010

"The systematic characterization of somatic mutations in cancer genomes is essential for understanding the disease and for developing targeted therapeutics."

So began today's journal article from a letter to Nature (link below) from scientists at Genentech.  They went on to state that they have looked at:

"The identification of 2,576 somatic mutations across 1,800 megabases of DNA representing 1,507 coding genes from 441 tumours comprising breast, lung, ovarian and prostate cancer types and subtypes. We found that mutation rates and the sets of mutated genes varied substantially across tumour types and subtypes.

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