Rituximab (Rituxan) May Delay MS Disability

In continuation of my update on rituximab

An immune system drug may help prevent or slow complications in a type of multiple sclerosis known as secondary progressive MS, a new study finds.

The medication is called rituximab (Rituxan). It's used to treat a number of conditions, including certain blood cell cancers and the autoimmune condition rheumatoid arthritis.

The new Swiss study found that MS patients taking the drug reported less disabling symptoms over a 10-year period than those who didn't. People taking rituximab also had a slower progression of MS symptoms.

It's important to note that the study was small, with 88 people, of whom only 44 received the medication, said Nicholas LaRocca, vice president of health care delivery and policy research for the National Multiple Sclerosis Society.

"This is a potentially valuable treatment, but there are still a lot of questions. Other studies are underway looking at the value of rituximab," LaRocca said.

With multiple sclerosis, the immune system turns against the central nervous system. Inflammation caused by the immune system damages a fatty substance called myelin that surrounds nerve cells, according to the National MS Society.

Symptoms of the disease vary from person to person, but may include fatigue, dizziness, problems walking, numbness or tingling, vision problems, pain, depression, bowel and bladder problems, muscle spasms and trouble with thinking and memory, according to the society.

MS usually begins as a relapsing-remitting disease. Sometimes it's active, and sometimes it's not. Most people with this form of MS will eventually transition to secondary progressive MS, which leads to more neurological problems and disability.

LaRocca said rituximab appears to work by affecting B-cells in the immune system. These cells have been implicated in the development of MS in other research, according to background information in the latest report.

In the study, researchers led by Dr. Yvonne Naegelin, from the University of Basel, Switzerland, compared 44 people with MS treated with rituximab to 44 people with MS who weren't given rituximab.

The volunteers who received rituximab were an average age of 50 and had been diagnosed with MS for about 18 years. The average age of the group that didn't receive rituximab was 51 and they had MS for an average of 19 years. The group that didn't receive rituximab was slightly less disabled, according to a disability scale.

Dr. Asaff Harel is a neurologist at Lenox Hill Hospital in New York City. He said, "This is an interesting, but limited, study that suggests that rituximab, a B-cell therapy, may be beneficial in the treatment of secondary progressive MS."

While those who got the drug tended to have lower progression of disabling symptoms, Harel said that "baseline differences in the two populations, such as age and the presence of relapses or new lesions, could cloud the results."

LaRocca said there was also a difference in the types of treatments the two groups had been exposed to prior to this study, which could have affected the results.

Rituximab isn't approved by the U.S. Food and Drug Administration for treating MS. Because of this, LaRocca said it wasn't clear if all insurance companies would cover its cost.

But, he said that it's reasonable for people to ask their physicians what they think of the drug and whether or not it might be an option for them.

Both experts said that more study is definitely needed to see if the drug is truly effective, along with answering other important questions, such as what's the optimal dose and how long can someone go between drug infusions?

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Rituximab (Rituxan) May Delay MS Disability for Some 

FDA approves combination of Venclexta and Rituxan for lymphocytic leukemia treatment

   

                   

  

Venclexta® (venetoclax)                                           Rituxan® (rituximab)     

In continuation of my update on Venclexta® (venetoclax)  and Rituxan® (rituximab)

Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Rituxan® (rituximab) for the treatment of people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.

"We are pleased that this approval makes Venclexta, a first of its kind targeted therapy, available for more people with chronic lymphocytic leukemia whose disease has returned after previous treatment," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "Venclexta plus Rituxan provides a new chemotherapy-free option shown to help people live longer without their disease progressing compared to a standard-of-care therapy."

The approval of Venclexta plus Rituxan for people with previously treated CLL is primarily based on the results of the Phase III MURANO study, which were published online in the New England Journal of Medicine in March 2018 and presented at the American Society of Hematology Annual Meeting in December 2017. The results showed that a fixed duration of treatment with Venclexta plus Rituxan significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 81 percent compared with bendamustine plus Rituxan, a current standard of care (HR=0.19; 95 percent CI 0.13-0.28; p<0.0001).

The most common side effects of Venclexta in combination with Rituxan include low white blood cell count, diarrhea, upper respiratory tract infection, cough, fatigue and nausea.

Today's FDA approval converts Venclexta's accelerated approval to a full approval. The FDA has also updated the indication for Venclexta as a single agent, which is now approved for the treatment of people with CLL or SLL, with or without 17p deletion, who have received at least one prior therapy. Venclexta was previously granted accelerated approval in April 2016 as a single agent for the treatment of people with CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.

The supplemental New Drug Application (sNDA) based on the MURANO data was granted Priority Review, a designation given to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The FDA also previously granted Breakthrough Therapy Designation for Venclexta in combination with Rituxan for the treatment of relapsed or refractory CLL. Venclexta in combination with Rituxan is recommended in the National Comprehensive Cancer Network (NCCN) guidelines as a treatment option for previously treated CLL (Category 1, Preferred).

An application for a variation of the marketing authorization based on the MURANO data has also been submitted to and validated by the European Medicines Agency (EMA). Additional submissions of the MURANO data to health authorities around the world are ongoing.

https://www.gene.com/media/press-releases/14728/2018-06-08/genentech-announces-fda-approval-for-ven

FDA approves combination of Venclexta and Rituxan for lymphocytic leukemia treatment

New Drug Combo Might Help Older, Sicker Patients With Leukemia

The research, led by German scientists, included nearly 800 older people (average age 73) who had been diagnosed with chronic lymphocytic leukemia. CLL is a cancer of the blood and bone marrow, the tissue inside bones in which blood cells are created.

The study was published online Jan. 8 in the New England Journal of Medicine. Study participants -- none of whom had received treatment for their illness before the start of the research -- were randomly assigned to one of three groups.

One group received an oral medication called chlorambucil (also known by the brand name Leukeran), the standard chemotherapy drug for older patients with CLL.

The second group received chlorambucil plus a drug called rituximab (Rituxan). This drug has been used effectively in combination with other forms of chemotherapy for more than a decade to treat younger, fitter patients with CLL, an expert said.

The third group received chlorambucil plus a new antibody drug called obinutuzumab. The rituximab and obinutuzumab were given intravenously.

The researchers, whose study was funded by the manufacturer of both obinutuzumab and rituximab, reported that the obinutuzumab-chlorambucil combination improved outcomes for the older CLL patients better than the other two treatment options.

The most common side effects for obinutuzumab are infusion reactions, low blood cell counts, fever, cough and musculoskeletal disorders, according to the manufacturer's website.

Dr. William Wierda, a professor in the department of leukemia at the University of Texas MD Anderson Cancer Center, said older patients don't tend to tolerate intensive chemotherapy with rituximab as well as younger patients. That has left older CLL patients with limited drug options, including chlorambucil, he said.

"We've been wanting to find a treatment that is effective and well tolerated in the elderly population," said Wierda, who was not involved with the new research. "A standard treatment for older patients with CLL has been chlorambucil, a type of chemotherapy that's been used for many years."

"The trial shows improvement in outcome remission rates and duration favoring patients who got chlorambucil and obinutuzumab," he said. "This was a head-to-head comparison of the two antibody arms of the study -- the rituximab and the obinutuzumab -- and obinutuzumab won out."

There also was an improvement in overall survival among the patients who received the obinutuzumab-chlorambucil combination treatment versus those who received chlorambucil alone, Wierda said.

New Drug Combo Might Help Older, Sicker Patients With Leukemia - Drugs.com MedNews

New Drug Combo Might Help Older, Sicker Patients With Leukemia - Drugs.com MedNews