GSK lands one-two punch in melanoma trial

Posted under ASCO, Blog, BRAF inhibitor, Companies, dabrafenib, Diagnostics, Funding, GlaxoSmithKline, Medical Devices, Medical Supply, Melanoma, personalized medicine, Pharmaceuticals, R&D, Roche, skin cancer, Startups, targeted therapies, trametinib, Universities, Videos, Zelboraf by rmcbride

GlaxoSmithKline ($GSK) is rushing to start a late-stage trial of an experimental cocktail therapy against deadly skin cancer after a mid-stage study produced impressive results. And data from the small trial provide early evidence that GSK's two-drug combo could have an edge over Roche's ($RHHBY) approved melanoma drug Zelboraf.

In the 77-patient study, those who took the combo of GSK's BRAF inhibitor dabrafenib and MEK-targeting agent trametinib lived for 7.4 months without their melanoma getting worse. Also, there were data to support that the combo could reduce a patient's risk of developing a separate cancer known as squamous-cell carcinoma while taking BRAF blockers, which are linked to growth of the tumors, Bloomberg reported.

Roche's Zelboraf is the first BRAF inhibitor approved for treating melanoma. GSK aims to stymie mutated forms of BRAF with dabrafenib, and pack the added punch of the MET-blocking trametinib to close an escape route that melanomas travel to skirt attacks from BRAF inhibitors. And despite the advance in care that Zelboraf has provided, about a third of patients on the drug develop cutaneous squamous-cell carcinoma and most patients' tumors eventually build up resistance to the targeted drug, Reuters reported.   

"We know that cancers are smart," said ASCO president-elect Dr. Sandra Swain, as quoted by Reuters. "They find work-around pathways. We are seeing a very innovative approach that ostensibly blocks off some of this pathway."

The results of GSK's study were revealed Wednesday as part of an avalanche of cancer trial news tied to next month's ASCO meeting, where the London-based drug giant will present the study and feed a frenzy in the oncology world for targeted treatments that are tailored for cancer patients based on the specific molecular drivers of their tumors.

Not surprisingly, GSK's combo is already drawing comparisons to Zelboraf. And Bloomberg noted that, while the London-based giant's study showed that its two-drug combo provided longer profession-free survival than Roche's BRAF inhibitor in similar studies, Roche pointed out to the news service that such comparisons are premature.

- check out Bloomberg's article
- see Reuters' report

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Support seen for U.S. plan to speed nods for ‘breakthrough’ drugs

Posted under Blog, Cancer Drugs, Companies, Diagnostics, FDA, Funding, HIV, Janet Woodcock, Kalydeco, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Regulatory, Startups, Universities, Videos, Xalkori, Zelboraf by rmcbride

Drug companies have clamored for the FDA to provide a more efficient pathway to gain product approvals, and this year the agency and U.S. lawmakers appear to be supportive of a plan that would help pharma groups race to the market with breakthrough drugs.

As Reuters reports today, the plan is expected to become law this year, formalizing a regulatory pathway that allows the FDA to let drugmakers conduct speedier trials with fewer patients prior to approval when their treatments provide major benefits for patients. The system would be akin to the agency's accelerated approach to ushering life-sustaining HIV treatments onto the market.

U.S. regulators have shown a willingness to take urgent action on reviews of breakthrough drugs. For instance, the agency stamped an approval of Vertex's ($VRTX) cystic fibrosis therapy Kalydeco after a quick three-month priority review rather than the standard 10-month review period. And the agency has acted quickly on applications for string of cancer meds such as Pfizer's ($PFE) lung cancer drug Xalkori and Roche's ($RHHBY) Zelboraf for skin cancer that showed impressive results in the clinic, Reuters reported.

Such approvals helped the industry see an uptick in market nods for new drugs, yet there are still significant barriers in place that keep development cycles even for powerful new meds long and expensive. Dr. Janet Woodcock, the FDA's top drug regulator, has been a vocal advocate for giving the agency greater latitude to approve breakthroughs.

"What happens when you have a breakthrough drug that shows an effect that's never been seen before?" Woodcock said in March, as quoted by Reuters.

- check out Reuters' article

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New Zelboraf data shows big survival boost

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Roche, Startups, Universities, Videos, Zelboraf by John Carroll

Roche's ($RHHBY) new melanoma drug Zelboraf apparently works even better than researchers suspected. Approved by FDA via its fast-track program, the targeted therapy demonstrated early on it improved survival time for patients with BRAF-positive melanoma. However, newly published trial data highlight median overall survival of almost 16 months, compared with 6 to 10 months for the typical patient with metastatic disease. Story

Roche gets key nod for targeted skin cancer drug en route to EU approval

Posted under Blog, Cancer Drugs, Companies, companion diagnostics, Diagnostics, Funding, Medical Devices, Medical Supply, Melanoma, Pharmaceuticals, Roche, Startups, Universities, Videos, Zelboraf by Ryan McBride

A standout drug for "personalized" skin cancer treatment has gained a key endorsement from European regulators. Roche ($RHHBY) said that the European Medicines Agency backed the targeted melanoma drug for approval. The Swiss drug giant hopes to secure from the European Commission in February.

The drug--developed by Daiichi Sankyo-owned biotech Plexxikon in Berkeley, CA--is intended to treat the aggressive forms of melanoma in which BRAF gene mutations are found, and Daiichi Sankyo's partner Roche is providing a companion diagnostic that screens patients for the mutation prior to treatment. The FDA approved the drug in August, after giving the market green light to Bristol-Myers Squibb's ($BMY) Yervoy for melanoma. Analysts expect sales of Zelboraf--which costs $56,000 for a six-month course of treatment--to reach nearly $1 billion in sales in 5 years, Reuters reported.

Zelboraf combats the deadliest form of skin cancer, and, unfortunately, one that has been on the rise. Globally, there were 200,000 new cases of melanoma in 2008, up from 160,000 cases in 2002, and the cancer kills about 40,000 people per year, according to figures cited by Roche. With fewer than one in four patients with the cancer expected to live beyond a year, Roche impressed clinicians last year with data that the drug, known generically as vemurafenib, reduced patients risk of dying by 63% during treatment compared to those on standard chemo treatments.

"The (Committee for Medicinal Products for Human Use) recommendation to approve Zelboraf represents an important milestone for people with metastatic melanoma who until recently had limited treatment options," Dr. Hal Barron, Roche's chief medical officer and head, global product development, said in a statement. "We are working closely with health authorities worldwide to bring Zelboraf to people with this deadly disease as soon as possible."

- here's the release
- read Reuters' coverage

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