Roche's combo lymphoma treatment wins U.S. FDA approval

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FILE PHOTO: The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann

(This June 10 story deletes paragraph 9 to clarify that retreatment with Polivy has not been studied.)

(Reuters) - The U.S. Food and Drug Administration on Monday granted earlier-than-expected approval to Roche Holding AG’s antibody- Polivy for treatment of patients with advanced lymphoma.

Polivy was approved in combination with Roche’s older drug Rituxan and a chemotherapy agent for adult patients with advanced diffuse large B-cell lymphoma (DLBCL) whose cancer has worsened despite at least two previous lines of therapy.

Antibody-drug conjugates are designed to deliver a toxic chemotherapy directly to tumors. Roche said the average U.S. list price for a four-month course of Polivy would be $90,000. Rituxan is priced at $39,500 for four months.

Wall Street analysts estimate Polivy sales at nearly $1 billion by 2024, according to IBES data from Refinitiv.

Side effects seen in studies of Polivy included low blood cell counts, nerve damage, fatigue and pneumonia, the FDA said in a statement.

Cell therapies Yescarta, from Gilead Sciences Inc and Kymriah, sold by Novartis AG, are also approved for patients with advanced DLBCL.

Dr. Matthew Matasar, a hematologist at New York’s Memorial Sloan Kettering Cancer Center who was involved in the development of Polivy, said the drug could be an option for some patients to try before determining whether they need to move on to CAR-T treatments.

Roche estimates that nearly 25,000 new cases of DLBCL, a type of non-Hodgkin’s lymphoma (NHL), will be diagnosed in the United States this year. NHL, which is one of the most common cancers, accounts for about 4% of all types of cancers in the United States, according to the American Cancer Society. Continued approval for the treatment may depend on data from a confirmatory trial, Roche said. The FDA’s accelerated approval program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.

Reporting by Aakash Jagadeesh Babu in Bengaluru and Deena Beasley in Los Angeles; Editing by James Emmanuel and Lisa Shumaker

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Listening to music may ease cancer patients' pain

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(Reuters Health) - Listening to music at home may reduce cancer patients’ pain and fatigue and ease symptoms like loss of appetite and difficulty concentrating, according to research in Taiwan.

In the study, breast cancer patients assigned to 30 minutes of music listening five times a week had “noticeably” reduced side effects of cancer and its treatment over 24 weeks, researchers report in the European Journal of Cancer Care.

The patients said the music helped their physical and psychological wellbeing because it distanced them from negative thoughts about cancer.

“Music therapy is convenient, does not involve invasive procedures, and can easily be used by people in the comfort of their homes,” said senior study author Kuei-Ru Chou of Taipei Medical University.

“Home-based music interventions can also be used with no cost,” Chou told Reuters Health by email. “Healthcare services have become expensive in the present time.”

The researchers recruited 60 breast cancer patients and randomly assigned half of them to a group that would listen to music at home on an MP3 player provided by the study team with a selection of classical, parlor, popular, Taiwanese and religious music to choose from. The other patients were also given a player and the same instructions about how often to listen, but their selections were various types of ambient music, mainly consisting of environmental sounds, which research has shown does little to reduce pain or symptoms, the study team notes.

Before the women had surgery, and after six, 12 and 24 weeks of music listening, all patients rated the severity of 25 physical symptoms on a five-point scale, as well as rating five categories of fatigue on a separate five-point scale, and the level of pain they felt on a 100-point scale.

The average symptom severity scores of the music therapy group had dropped by five points at the six-week assessment, seven points at 12 weeks and nearly nine points after 24 weeks. Pain scores and overall fatigue scores fell at each assessment as well.

For those listening to music, physical and mental fatigue had also dropped at six weeks but not later.

In contrast, pain and symptom severity scores in the control group increased and remained higher than at the start of the trial.

Based on the results, music therapy may not relieve long-term physical and mental fatigue, the study authors caution. And future studies should use objective measures of pain and fatigue, in addition to the subjective measures used in this study, Chou said.

The researchers are also interested in learning how and why music therapy reduces symptoms and pain. Because listening to music promotes endorphins, dopamine and serotonin in the brain, the chemicals may spark joy and positive emotions that distract patients from the negative emotions, the study authors speculate.

Music could affect functions of the cardiovascular, respiratory, muscular, skeletal, nervous and metabolic systems as well, relieving muscle tension and pain, they add.

“From the neurophysiological point of view,” said Tereza Alcantara-Silva of the Federal University of Goias in Brazil, music-evoked emotions can modulate activity in a variety of brain areas.

“Music plays a major role in self-regulation of emotional contexts,” said Alcantara-Silva, who wasn’t involved in the study, by email. “Music therapy can bring several benefits to cancer patients, helping them to find ways to deal with stress, fear, and loneliness.”

SOURCE: bit.ly/2Idu5cY European Journal of Cancer Care, online June 5, 2019.

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