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

Our Standards:The Thomson Reuters Trust Principles.

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Swiss women stage mass strike demanding overdue equality

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GENEVA/ZURICH (Reuters) - Hundreds of thousands of women across Switzerland held a strike on Friday to highlight their wealthy nation’s poor record on female rights, recreating the passion of the last such walkout 28 years ago.

In Zurich, the financial capital and the country’s biggest city, tens of thousands of protesters clogged the streets, blowing whistles and banging pots and pans. “Men, go do the ironing,” one sign read.

“It’s not just about wages. The equal opportunity is not there. At least for the next generation it needs to be there,” Zurich city councilwoman Karin Rykart said as hundreds of municipal workers and police officers demonstrated.

Despite its high quality of life, Switzerland lags other developed economies in female pay and workplace gender equality.

Friday’s event echoed a strike in 1991, five years before the Gender Equality Act came into force. That banned workplace discrimination and sexual harassment and protected women from bias or dismissal over pregnancy, marital status, or gender.

But more than 20 years later, women still earn less than men, face routine questioning of their competence, and encounter condescension on the job, they say.

Organisers say the strike draws attention to wages, violence against women, and the need for greater representation in positions of power and more equitable family policy.

Christine Lagarde, the first woman to lead the International Monetary Fund, joined in while addressing an event in Geneva.

Protesters carry banners and placards at a demonstration during a women's strike (Frauenstreik) in Zurich, Switzerland June 14, 2019. REUTERS/Arnd Wiegmann

“At this point in time if I were true to my colors I would actually turn my back to you and express in that way the fact that I am actually on strike - but you might be disappointed,” she said.

“So instead of this I am actually wearing this (lapel pin) out of solidarity with the Swiss women who claim equality in terms of salaries and a few other things.”

The SGB labor union federation estimated 100,000 people joined the strike by midday, with more participating from 3:24 p.m., when women technically work for free given wage discrimination.

“THINGS DIDN’T CHANGE”

Swiss women earn roughly 20% less than men. While that is an improvement from about a third less in 1991, the discrimination gap — meaning differences that cannot be explained by rank or role — has actually worsened since 2000, government data show.

On June 14, 1991, women blocked trams during a sit-in in the heart of Zurich’s financial district and gathered outside schools, hospitals and across cities with purple balloons and banners to demand equal pay for equal work.

That came a decade after basic gender equality was enshrined in the Swiss constitution and less than three months after women for the first time were allowed to participate in a regional vote in the canton of Appenzell Innerrhoden.

“We have realized that even after this first strike in 1991, things didn’t really change. Equality is enshrined in the constitution, but real, material, effective equality doesn’t exist for all women,” said organizer Tamara Knezevic, 24.

Slideshow (32 Images)

The World Economic Forum found Switzerland ranked 34th for economic participation and opportunity and 44th for wage equality in a 2018 study of 149 countries.

See Factbox on 9 leading Swiss women

Additional reporting by Denis Balibouse in Lausanne and Stephanie Nebehay in Geneva; Editing by Andrew Cawthorne and Raissa Kasolowsky

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WHO likely to declare Ebola an international emergency: experts

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GENEVA (Reuters) - The World Health Organization (WHO) should and is likely to declare an international emergency over the Ebola epidemic in the Democratic Republic of Congo that has now spread to Uganda, experts said as a WHO advisory panel met on Friday.

A health worker wearing Ebola protection gear enters the Biosecure Emergency Care Unit (CUBE) at the ALIMA (The Alliance for International Medical Action) Ebola treatment centre in Beni, in the Democratic Republic of Congo, April 1, 2019. Picture taken April 1, 2019.REUTERS/Baz Ratner

Congo’s epidemic is the second worst worldwide since West Africa’s Ebola outbreak in 2014-16, with 2,084 cases and 1,405 deaths since being declared in August. The WHO said on Thursday that two people had died in Uganda having arrived with the disease from Congo.

A panel of 13 independent medical experts on the WHO’s Emergency Committee (EC) were meeting from midday to evaluate the latest evidence and whether the epidemic constitutes a Public Health Emergency of International Concern (PHEIC).

Such a decision would lead to boosting public health measures, funding and resources, and could include recommendations on trade and travel, academic experts and aid groups said.

“Will @WHO declare global emergency for #Ebola? I predict yes. My sense is @DrTedros will call PHEIC if #EC recs it. He understands depth of crisis,” Lawrence Gostin, professor of global health law at Georgetown University Law School in Washington, D.C., who is not on the panel, said in a tweet.

People are still dying outside of Ebola treatment centers - exposing their families to the disease - and many don’t appear on lists of known contacts being monitored, he said.

“Vaccines alone can’t work if community hides cases due to distrust. Violence persists. We are in this for the long haul,” Gostin said, referring to deadly attacks on Congo health facilities.

The panel, which twice before decided not to declare an emergency, will make recommendations to WHO director-general Tedros Adhanom Ghebreyesus who takes the final decision.

Only 4 emergencies have been declared in the past decade: the H1 virus that caused an influenza pandemic (2009), West Africa’s Ebola outbreak, polio (2014) and Zika virus (2016).

SECOND WORST EPIDEMIC

Top WHO official Mike Ryan said on Thursday there had been no known person-to-person spread of Ebola in Uganda and that there were encouraging signs in Congo, with the disease’s spread slowing in cities of Butembo and Katwa. However it the virus was now entrenched in rural areas including Mabalako, he said.

“But these can be very volatile, these can go up and down week to week. So we have to be careful looking at one week of data and declaring victory.

“We have a hell of a long way to go in this response,” he told Reuters.

The WHO, in a statement overnight, said that given all three confirmed cases in Uganda belong to a single family cluster, the level of preparedness and experience of Ugandan authorities to manage previous Ebola outbreaks, and their rapid detection of cases in a limited geographical area, “the overall level of risk at national level is assessed as moderate”.

“However, the overall regional risk posed by the outbreak in DRC remains very high. The overall risk at international level remains low,” it said.

Jeremy Farrar, director of the Wellcome Trust global medical charity, said the WHO should declare a public health emergency of international concern.

“Doing so would raise the levels of international political support, which has been seriously lacking so far, show strong support for DRC and neighboring countries and WHO, and release more resources, including finance, healthcare workers, enhanced logistics, security and infrastructure,” he said.

Additional reporting by Kate Kelland in London; Editing by Raissa Kasolowsky

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