Vismodegib drug shows no addded benefit in advanced or symptomatic metastatic BCC patients

  

Vismodegib (trade name: Erivedge) has already been approved since 2013 for the treatment of patients with locally advanced basal cell carcinoma (BCC) or symptomatic metastatic BCC and has already undergone an early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG). The Federal Joint Committee (G-BA) limited its decision in February 2014 to two years, which is why the drug manufacturer now submitted a new dossier.

In its second early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) came to the same conclusion as in the first one: The data presented on the drug showed no superiority in comparison with the appropriate comparator therapy. Hence an added benefit of vismodegib is still not proven.

No better data two years later

The appropriate comparator therapy was best supportive care (BSC), i.e. an individual combination of the best possible supportive treatments. According to the G-BA, this can also include surgery or radiotherapy for patients with symptomatic metastatic BCC, which is not the case in locally advanced BCC.

As already in the first dossier, the manufacturer presented no data from randomized or non-randomized comparative studies that would be suitable for the assessment of an added benefit of vismodegib for patients with symptomatic metastatic BCC or with locally advanced BCC. In the newly submitted data from four one-arm intervention studies, patients with symptomatic metastatic BCC cannot be differentiated from study participants with metastases, but without symptoms (metastatic BCC), for example. Furthermore, study results on the outcome "objective response rate" were not presented adequately for locally advanced BCC patients; there was no information on size, number and location of skin lesions, for example. Hence the manufacturer did not implement one of the conditions of the G-BA's Limitation.

Manufacturer's assumptions on BSC not justified

Moreover, a simplified search conducted by IQWiG showed that the study pool on locally advanced BCC in the dossier was incomplete. The manufacturer stated that it had found no studies on BSC, for example. Besides two further potentially relevant studies, IQWiG identified one study (Horn 2003), however.

This study runs counter to the manufacturer's assumptions that no studies on BSC in patients with locally advanced BCC existed and that it could be assumed that patients with locally advanced BCC do not respond to BSC:In the study, 75 per cent of the patients with locally advanced BCC responded completely after three months; after 24 months, these were still at least 50 per cent. Furthermore, the manufacturer claimed that nothing was known on the occurrence of adverse events in BSC. The study Horn 2003 actually addressed this outcome, however: No serious adverse events were reported.

Overall, there was no hint of an added benefit of vismodegib in comparison with the appropriate comparator therapy for any of the two research questions.

Vismodegib drug shows no addded benefit in advanced or symptomatic metastatic BCC patients: Vismodegib (trade name: Erivedge) has already been approved since 2013 for the treatment of patients with locally advanced basal cell carcinoma (BCC) or symptomatic metastatic BCC and has already undergone an early benefit assessment according to the Act on the Reform of the Market for Medicinal Products.

Vismodegib team wins Drug Discovery of the Year award

In continuation of my update on Vismodegib

Vismodegib team wins Drug Discovery of the Year award: The British Pharmacological Society proudly announces that its first annual Drug Discovery of the Year award has been won by the discovery team developing vismodegib for the treatment of basal cell carcinoma (a type of skin cancer).

NEJM hails vismodegib as ‘the greatest advance in therapy yet seen’ for advanced BCC

In continuation of my update on Vismodegib

NEJM hails vismodegib as ‘the greatest advance in therapy yet seen’ for advanced BCC

Vismodegib is an effective treatment for patients with basal cell carcinomas

 Vismodegib :


Vismodegib is an effective treatment for patients with basal cell carcinomas

Combination [of Vismodegib (GDC-0449) and Gemcitabine] therapy may help defeat pancreatic cancer

 In continuation of my update on (GDC-0449) Visodegib and Gemcitabine

GDC-0449 targets the Smoothened (SMO) protein in the Hedgehog signaling pathway. It was approved for use in basal cell carcinoma and is marketed as vismodegib. Kim and his colleagues felt that treating patients with pancreatic cancer first with GDC-0449 and then with the standard chemotherapeutic drug gemcitabine might disrupt the desmoplastic stroma and improve the efficacy of the chemotherapy. 

They evaluated this strategy in treatment-naive patients with advanced pancreatic cancer. Patients underwent needle biopsies of the cancer before and after taking GDC-0449 for three weeks to study the effects of GDC-0449 on the Hedgehog pathway signals, tumor stroma and pancreatic cancer stem cells. Gemcitabine was added to GDC-0449 following the second biopsy.

Combination therapy may help defeat pancreatic cancer

Drug shows promise as skin cancer treatment

In continuation of my update on Vismodegib

Drug shows promise as skin cancer treatment: A new vismodegib, drug for a type of skin cancer caused by a rare genetic disease can not only substantially shrink the tumors, but can also prevent the growth of new cancers, US investigators have discovered.

Genentech receives FDA approval for Vismodegib to treat skin cancer

In continuation of my update Vismdegib

Genentech receives FDA approval for Vismodegib to treat skin cancer: A new skin cancer drug tested for the first time in the world five years ago at the Virginia G. Piper Cancer Center at Scottsdale Healthcare just received expedited approval by the U.S. Food and Drug Administration, a remarkable accomplishment in new drug development.

New drug found effective against rare form of basal cell skin cancer

In continuation of my up date on vismodegib..

A clinical study has demonstrated that a new drug, a targeted molecular therapy called vismodegib (trade name Erivedge™), can dramatically shrink basal cell skin cancers and prevent the formation of new ones, in patients with basal cell nevus syndrome (BCNS). This rare genetic condition causes dozens, and sometimes hundreds or thousands, of skin cancers on each patient's body. The primary treatment option is surgical removal. These study results are significant as they indicate the possibility of an alternative treatment with oral medication; although side effects remain a consideration. 

New drug found effective against rare form of basal cell skin cancer

Erivedge Approved to Treat Basal Cell Carinoma

Erivedge(vismodegib) has been approved by the U.S. Food and Drug Administration to treat the most common form of skin cancer, basal cell carcinoma, the agency said Monday.

The drug was approved for people for whom surgery or radiation aren't options, and for people with basal cell that has spread to other parts of the body, according to an FDA news release. Erivedge was evaluated in clinical studies involving 96 people with basal cell carcinoma. The most common side effects included muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted taste, loss of appetite and constipation.

The drug was approved with an FDA's label warning that pregnant women who take Erivedge could have babies at greater risk of severe birth defects or death. "Pregnancy status must be verified prior to the start of Erivedge treatment," the agency release advised.

Ref : http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13827