ZURICH, Dec 6 – Swiss drugmaker Roche Holding AG <ROG.VX> presented the results of studies on two drugs in mid-stage development that may go some way towards addressing concerns about the strength of the company's drug pipeline.

Roche, the world's largest maker of cancer drugs, said on Monday that eight-week results from a phase II study of an investigational drug for the treatment of schizophrenia showed it reduced the negative symptoms of the condition and helped patients better deal with personal and social situations.

The study measured improvements in patients with mostly negative symptoms of schizophrenia who received the drug, a schizophrenia Glycine reuptake inhibitor called RG1678, in combination with second-generation antipsychotics.

The company also said results from another phase II study yielded promising results in difficult-to-treat patients with a common type of blood cancer.

Roche, best known for its widely-used cancer drugs, has said it wants to broaden its business beyond oncology and sees blockbuster sales potential for several experimental drugs.

The group has faced a series of setbacks with its top-selling cancer drug Avastin and an experimental rheumatoid arthritis drug called ocrelizumab. [ID:nLDE62I06Q]

The drugmaker said last month it would cut 4,800 jobs or 6 percent of its workforce over the next two years in order to save 2.4 billion Swiss francs per year from 2012 onwards as it grapples with recent product setbacks and mounting pressure on prices. [ID:nLDE6AF29X] (Reporting by Martin de Sa'Pinto and Silke Koltrowitz; Editing by Jon Loades-Carter)

The FDA faces a key decision this month on whether to rescind approval of Roche’s expensive cancer drug Avastin for treating breast cancer. The drug slightly delays the time it takes tumors to grow on a scan, but has failed to show it can either improve symptoms or help women live longer in various large trials.  One possibility is that side effects are canceling out the benefits of slowed tumor growth.

The decision could set a precedent for how the FDA deals with expensive, marginally effective cancer drugs in the future.  Some top cancer researchers believe that we have set the bar too low by allowing drugs to be approved based purely on statistical measures of efficacy–as opposed to looking at whether tiny differences in time to tumor growth of a month or six weeks are medically meaningful.  One drug, Tarceva for pancreatic cancer, improves survival by just two weeks.

Should the FDA should consider cost explicitly in their calculations?  All the new cancer drugs are enormously expensive. Avastin can cost up to $55,000 a year. Some other drugs cost $100,000 a year or more. if they were cheap, there might not be the debate about the marginal effectiveness.

Forbes senior editor Matt Herper thinks the FDA should consider cost.  I think it is a bad idea to allow explicit cost consideration–even if the issue is always lurking in the background. it would lead to ever more cries of death panels, and a political controversy that would undermine the agency’s credibility as a fair arbiter of drug safety and effectiveness.  Just because society isn’t willing to address the question of how much is it willing to pay for slightly better cancer drugs, doesn’t mean the FDA should be forced to take on the job. Click here for a debate:

* Effect is short-lived; may need to be part of cocktail * Late-stage tests now under way by Gene Emery BOSTON, Aug. 25 (Reuters) – an experimental targeted cancer drug from Roche <ROG.VX> and privately held Plexxikon shrank advanced melanoma tumors in 81 percent of patients with the deadly and hard-to-treat cancer, doctors said on Wednesday. The findings were part of an early phase study used to determine the best dose of the experimental drug PLX4032, now in late-stage clinical trials. It is designed to target tumor cells with a mutation in a gene called BRAF. In two patients, tumors went away completely. In 24 others, the tumors shrank by more than 30 percent, the team reported in the New England Journal of Medicine. The team said 81 percent of 32 patients with a BRAF mutation showed complete or partial shrinkage of their tumors. "We can see the improvement in patients and it’s happening quite rapidly, within a week or two of starting treatment," Dr. Keith Flaherty of the Massachusetts General Hospital in Boston said in a telephone interview. "for patients without symptoms, the hope is that it delays the time it takes for them to develop symptoms, and we have some belief that that is happening as we speak," said Flaherty, who worked on the study. but the effect appears to be fleeting. In all but two cases, where the cancer has stayed away for at least a year, the benefits have been temporary, typically lasting about six months, Flaherty said. The hope is that the drug can be combined with other treatments to produce a long-lasting effect, comparable to the AIDS cocktail that maintains the health of many people with HIV, he said. Preliminary findings with the new drug were reported in September 2009, but the data from more patients have been added, boosting confidence in its prospects. [ID:nLN694676] Tumors shrank at all sites where the tumor had spread, including the bone, liver and small bowel. Cancer-causing mutations in the BRAF gene occur in 50 percent to 60 percent of melanoma patients. SECOND DRUG Researchers are eager to test the drug with Bristol-Myers Squibb’s <BMY.N> experimental drug ipilimumab, the first treatment shown to extend lives of patients with advanced melanoma. [ID:nLDE6560C0] In June, researchers reported that more than 20 percent of patients with advanced melanoma were alive two years after treatment with ipilimumab — compared with a usual nine months. Ipilimumab or "ipi" is a monoclonal antibody, an engineered version of a human protein that targets CTLA-4, a molecule that acts like a brake on the immune system. "The data provided by Flaherty and colleagues represent a major advance in the treatment of metastatic melanoma," Keiran Smalley and Dr. Vernon Sondak of Moffitt Cancer Center and Research Institute in Tampa, Florida, said in a commentary in the same journal. side effects included rash, fatigue, joint pain and a high risk of a different type of skin cancer known as cutaneous squamous-cell carcinoma. of 87 patients enrolled in both stages, 18 developed such tumors, which are easier to treat. The BRAF mutation is also found in about 8 percent of solid tumors, suggesting the drug might be effective in other forms of cancer. Melanoma is the most aggressive form of skin cancer, affecting 160,000 people worldwide each year. when melanoma has spread, conventional chemotherapy is typically effective only in 10 percent to 20 percent of the cases. (Editing by Julie Steenhuysen and Steve Orlofsky)