Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts from the ‘News’ category

Update on cabozantinib in medullary thyroid cancer

This morning, Exelixis announced results from the cabozantinib phase III EXAM trial in medullary thyroid cancer (MTC).  I last wrote about this compound as XL184 in MTC three years ago in the phase I trial, so it’s definitely time for an update!  A lot has happened since then, including BMS, Exelixis’ then partner, deciding not to pursue the agent’s development.

With a new announcement today from Exelixis, it now appears that median progression free survival (PFS) in the phase III trial, based on a planned interim analysis, was superior in the cabozantinib arm compared to that of placebo. Topline analysis yielded an improvement of 7.2 months (11.2 months versus 4.0 months, HR=0.28, p < 0.0001). The primary endpoint was PFS and no overall survival (OS) is yet available.

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Pharma Strategy Blog feed is back up

Last week’s post on ovarian cancer caused the blog feed that drives RSS, email alerts and the Kindle to fall over, apologies to all for that inconvenience!  A stray and errant dot in one of the P values appears to have been the culprit for some strange reason.

The good news is that it is now fixed and all is back up and running again.  Many thanks to all who contacted PSB to alert me of the problem.

Over the last few weeks I’ve had quite a few requests to sign up for the blog via email or other means.

ASCO Breast Cancer Symposium 2011

Today brings us the annual American Society of Clinical Oncology (ASCO) breast cancer symposium from San Francisco.

Screenshot 2011 09 07 300x83 ASCO Breast Cancer Symposium 2011Sadly I’m not attending due to other commitments, but there will likely be a number of people there who will be tweeting the event. The official hashtag #BCS11 so it seemed a great opportunity to keep track of them for everyone interested in easily reading them all in one place.

You can click on the conference widget below at any time and follow the conversation from attendees and those remote from San Francisco:

My take on the crizotinib Xalkori FDA approval

Pfizer’s Crizotinib (Xalkori) approved in ALK-positive lung cancer!

The FDA just announced that they have approved Pfizer’s crizotinib (Xalkori):

The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.

Xalkori is being approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit. It is the second such targeted therapy approved by the FDA this year.

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Seattle Genetics announce fast track approval of Adcetris

This morning, Seattle Genetics announced that the expected fast track approval from the FDA has been forthcoming for brentuximab vedotin (Adcetris) following the recent unanimous ODAC voting in both refractory Hodgkin Lymphoma (HL) and Anaplastic Large Cell Lymphoma (ALCL).  Clearly, the company and the agency have come to agreement on the confirmatory trials as part of the condition of accelerated review.  The final prescribing information (PI) can be found on the Adcetris website.

For those of you looking for more information on Adcetris, please check out the related posts section below for previous reports on this novel ADC therapy.

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Zelboraf approved by the FDA in BRAF V600E metastatic melanoma

This morning the FDA approved vemurafenib (Zelboraf), along with it’s companion diagnostic, for the treatment of metastatic melanoma in patients with the BRAF V600E mutation.

This is great news!

ZELBORAF logo 300x116 Zelboraf approved by the FDA in BRAF V600E metastatic melanoma

The approval has been granted ahead of time, as correctly mentioned in the Reuters article recently. This means we now have two new therapies for the treatment of metastatic melanoma after ipilimumab (Yervoy) was approved in March.

These two new drugs have been rapidly approved within the space of a couple of months following the presentation of the data at the ASCO plenary session in June.

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On T cells and chronic lymphocytic leukemia

Late last week saw an incredible amount of noise in the media over the startling news that three patients with chronic lymphocytic leukemia (CLL) had responded well to an experimental gene therapy that aimed to boost T cells to fight a particular type of leukemia, some of it, unfortunately, bordering on near hysterical hype, such as MSNBC’s article entitled:

“New leukemia treatment exceeds ‘wildest expectations’”

Ugh.  There were others in similar vein, mostly derived from the AP and Reuters press releases.  Quite frankly, with a headline like that I was expecting something more substantial and robust than three patients.

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Will vemurafenib receive early approval for metastatic melanoma?

A Reuters press release on vemurafenib (Zelboraf) caught my eye this morning, suggesting that it might be approved in BRAFV600E metastatic melanoma by the FDA might be “imminent” according to an unnamed source and much earlier than the expected PDUFA date in November October 28th (now confirmed by Roche/Genentech).

If so, that’s very good news.

However, what really caught my eye was a quote from a spokesperson at Roche Diagnostics, suggesting that the BRAFV600E test would could around $150.  That’s lower than I was expecting, although no doubt it will be considerably offset by the cost of vemurafenib itself.

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National Lung Cancer Screening results and their potential impact

“Current and former heavy smokers can now be screened more effectively for lung cancer. Results from the National Lung Screening Trial (NLST) revealed that detecting small lung cancers with computed tomography (CT) reduces lung cancer specific mortality by 20 percent.”

MD Anderson Cancer Center (MDACC) press release

Wow, how amazing is that?  Thanks to the MDACC Provost, Dr Ray DuBois for sharing it on Twitter and to Dr Jack West (Swedish) for Re-Tweeting it or I may well have missed it. The action is as a direct result of The National Lung Screening Trial (NLST), which was conducted to evaluate whether screening with low-dose CT scans could reduce mortality from lung cancer.

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Some inspirational reading for the Memorial weekend

Memorial Day weekend is traditionally the last weekend before the annual American Society of Clinical Oncology (ASCO) meeting and we will be busy working as usual as part of the last preparations for the event.

Today, I’d to share some interesting blogs that you may not have come across to broaden your reading:

  1. Jody Schoger, a breast cancer survivor wrote a superb post about ‘Anchored activism’ in Oncology Times. She will be writing a regular blog there later this year, she’s a thoughtful and provocative read.