Tag Archives: cancer treatment

U.S. high court’s Ginsburg misses arguments after cancer surgery

FILE PHOTO: U.S. Supreme Court Associate Justice Ruth Bader Ginsburg is seen during a group portrait session for the new full court at the Supreme Court in Washington, U.S., November 30, 2018. REUTERS/Jim Young/File Photo

By Andrew Chung

WASHINGTON (Reuters) – Justice Ruth Bader Ginsburg on Monday missed oral arguments for the first time since joining the U.S. Supreme Court in 1993 as the 85-year-old liberal jurist continues to recuperate from lung cancer surgery last month.

Chief Justice John Roberts addressed Ginsburg’s absence before the first of the day’s two arguments in cases before the court, saying she was “unable to be present today.” Ginsburg instead will work from home and use the case briefs and argument transcripts to participate in the cases, court spokeswoman Kathy Arberg said.

Ginsburg, the oldest member of the nine-justice court, underwent a surgical procedure called a pulmonary lobectomy on Dec. 21 at Memorial Sloan Kettering Cancer Center in New York to remove two cancerous nodules in her left lung and was released from the hospital on Dec. 25.

Monday’s arguments were the first on the court’s schedule since her surgery. After the procedure, the court said there was no evidence of remaining disease. It is not known whether Ginsburg will attend the court’s oral arguments in more cases on Tuesday and Wednesday.

It was the first time Ginsburg, one of the court’s nine justices, has missed oral arguments as a result of her various health scares, including two previous cancer diagnoses. Ginsburg participated in the court’s private meeting last Friday in which the justices voted on which new cases to take up, but was not present at the court, Arberg said.

As the oldest justice, Ginsburg is closely watched for any signs of deteriorating health. Ginsburg, appointed by Democratic President Bill Clinton, also is the senior liberal member of the court, which has a 5-4 conservative majority.

Ginsburg broke three ribs in a fall in November. The nodules were found as part of the tests the justice underwent after the earlier fall, according to the court.

Ginsburg was treated in 1999 for colon cancer and again in 2009 for pancreatic cancer but did not miss any argument sessions either time. In 2014, doctors placed a stent in her right coronary artery to improve blood flow after she reported discomfort following routine exercise. She was released from a hospital the next day.

She is viewed as something of a cult figure for U.S. liberals, known by the nickname “Notorious RBG,” after the late rapper Notorious BIG. A documentary film, “RBG,” and a feature film about her life, “On the Basis of Sex,” were released in 2018.

If Ginsburg were unable to continue serving, Trump could replace her with a conservative, further shifting the court to the right.

(Reporting by Andrew Chung. Additional reporting by Lawrence Hurley; Editing by Will Dunham)

Too many cancer drugs? Crowded market gives investors pause

FILE PHOTO: A scientist prepares protein samples for analysis in a lab at the Institute of Cancer Research in Sutton, July 15, 2013. REUTERS/Stefan Wermuth/File Photo

By Ben Hirschler

LONDON (Reuters) – In London’s world-famous Great Ormond Street children’s hospital, Dr. Karin Straathof is excited about a new cell-based medicine that offers hope for toddlers with incurable nerve tissue cancer.

Her progress with a handful of children for whom standard care does not work reveals the promise of modern cancer drugs, an increasingly crowded pharmaceuticals field from which investors must try to select future winners.

The new therapy using engineered white blood cells has shown anti-tumor activity in the hardest to treat neuroblastoma patients.

“The beauty is that it is very specific in targeting the cancer cells, while leaving healthy tissue unharmed,” Straathof told Reuters, after presenting her early findings at a science meeting in Chicago in April. “It’s an important step forward.”

Autolus – the small British biotech company developing the chimeric antigen receptor T-cell or CAR-T treatment – is equally excited, and is planning a potential IPO on Nasdaq.

But Autolus is far from alone in pursuing CAR-T therapy. In fact, CAR-T treatment – part of the wider field of cancer immunotherapy – is one of the hottest areas of drug research today, with multiple firms piling in.

The biotech dollars are flooding in not only in Europe and the United States but also in China which, with 162 clinical trials, now boasts more CAR-T studies than the United States, according to a Reuters analysis of the latest data.

With over 2,000 drugs in the cancer immunotherapy space, the competitive landscape has never been more crowded as each firm seeks its own proprietary version of often similar drugs.

Overall, researchers are working on more than 5,200 cancer drugs, up 7.6 percent from a year ago, according to the Pharmaprojects database. The sheer number is stretching the ability of scientists to find enough patients to test them on.

Cancer now makes up 34.1 percent of the total drug industry pipeline, up from 26.8 percent in 2010, as companies divert resources into a promising sector where new treatments can often fetch more than $100,000 a year.

‘MORE CIRCUMSPECT’

With the first two CAR-T treatments from Novartis and Gilead Sciences winning U.S. approval last year for rare blood cancers, the promise of such smart medicine is real and life-changing – especially if it can be made to work in solid tumors, as Straathof’s work suggests is possible.

However, the wholesale rush by pharmaceutical and biotech companies into the cancer area poses a dilemma for investors.

A flood of similar products makes it hard for investors to pick those companies that will achieve commercial success.

“More competition means you should be more circumspect,” said Nooman Haque, head of life sciences at Silicon Valley Bank in London, which provides financing for start-ups and venture capitalists.

“The traditional investment thesis in biotech is to have a differentiated medicine with not many competitors, which helps drive value. Here the problem is that even if there is a big patient benefit, there are questions as to how long your advantage lasts and what your commercial edge will be.”

Pharmaceutical executives are not blind to the issue, although each hopes to find a winning formula in immunotherapy – the fastest-growing part of the $100 billion-a-year cancer drug market, with sales expected to top $25 billion by 2021, according to analyst forecasts compiled by Thomson Reuters.

Roche <ROG.S> CEO Severin Schwan, head of the world’s top cancer company, says he expects “an enormous drop-out”, while Sanofi’s  outgoing research head Elias Zerhouni warned analysts last week that duplication of effort would shrink the time available for drugmakers to recoup their  investments.

“The cycle of innovation has been shortened significantly,” agrees Aiman Shalabi, chief medical officer at the non-profit Cancer Research Institute. “There is no doubt we are seeing fast follow-on and many identical agents hitting the same targets.”

The good news for society is that patients will find out much faster than in the past if new approaches work. But that means doctors can rapidly switch to alternatives, leading to increased product churn and uncertainty over future sales.

COMBINATION STUDIES

Twenty years ago, when Roche launched its state-of-the-art cancer drugs Herceptin and Rituxan, it enjoyed years without rivals. Today, there are multiple versions of new drugs targeting molecular pathways with acronyms such as PD-1/L1, PARP and CDK, as well as CAR-T.

“You’re either first or you’re best or you’re nowhere because it has become such a race,” said Paul Major, an investment manager at BB Healthcare Trust, who is cautious about investing in cancer immunotherapy.

Lydia Haueter at Pictet Asset Management is also wary, pointing out there are already five PD-1/L1 drugs on the market – from Merck, Bristol-Myers Squibb, Roche, AstraZeneca and Pfizer – and more are coming.

“It seems everybody has a PD-1, so we especially don’t go for those kind of cancer companies,” she said.

Some drugmakers like GlaxoSmithKline <GSK.L> and Novartis that missed the initial PD-1/L1 wave are trying to make a virtue of looking ahead to the next phase of cancer immunotherapy, particularly drug combinations.

Yet last month’s failure of a combination study using a next-generation drug from Incyte with Merck’s PD-1 Keytruda shows that adding a new agent is no slam dunk for expanding the reach of immune-boosting medicine.

At Great Ormond Street, Straathof is less concerned about doubling up on research and more focused on getting effective, affordable cures – and she hopes automated processes will eventually bring down today’s sky-high drug prices.

“I’m not too worried about duplication. It’s important to not ask the same question in two trials but I think there are a lot of questions to be addressed because there is a lot of nuance in the system.”

(Reporting by Ben Hirschler; Editing by Pravin Char)

U.S. Senate joins House to pass sweeping new health bill

A participant prepares to receive an antibody infusion of a drug that is part of a clinical trial for a functional HIV cure at the National Institutes of Health in Bethesda, Maryland, U.S. November 22, 2016 in this still image from video.

By Toni Clarke

(Reuters) – The U.S. Senate voted overwhelmingly on Wednesday to support sweeping legislation that will reshape the way the Food and Drug Administration approves new medicines.

It will also provide funding for cancer and Alzheimer’s research, help fight the opioid epidemic, expand access to mental health treatment and advance research into precision medicine.

Two years in the making, the 21st Century Cures Act was passed last week by the House of Representatives and will now go to President Barack Obama to sign into law. Supporters say it will speed access to new drugs and devices, in part by allowing clinical trials to be designed with fewer patients and cheaper, easier-to-achieve goals.

“For the second consecutive year, the Senate is sending the President another Christmas miracle for his signature,” Senator Lamar Alexander, a Republican from Tennessee said in a statement. “Last year, it was the Every Student Succeeds Act, and this time, it’s the 21st Century Cures Act — a bill that will help virtually every American family.”

Critics of the legislation say it gives massive handouts to the pharmaceutical industry and will lower standards for drug and medical device approvals.

“This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices,” consumer watchdog Public Citizen said in a statement.

Democratic Senator Elizabeth Warren was among the handful of senators who voted against the bill, as was independent senator and former Democratic presidential candidate Bernie Sanders. Each decried what they described as big handouts to the pharma industry. Even so the bill passed 94-5. The House passed it by a vote of 392-26.

The $6.3 billion act, sponsored by Republican Representative Fred Upton, authorizes $4.8 billion for the National Institutes of Health and $500 million to the Food and Drug Administration.

It also calls for $1 billion over two years to battle the opioid epidemic. On Tuesday the Drug Enforcement Administration issued a report showing that in 2014 about 129 people died every day as a result of drug poisoning. Of those, 61 percent are opioid or heroin related.

“Opioids such as heroin and fentanyl – and diverted prescription pain pills – are killing people in this country at a horrifying rate,” Acting Administrator Chuck Rosenberg said. “We face a public health crisis of historic proportions.”

The bill also calls for $1.8 billion in funding for Vice President Joseph Biden’s Cancer Moonshot initiative designed to bolster cancer research by reducing bureaucracy and promoting research collaboration.

Critics note that the money described in the bill must be appropriated by separate funding bills and that the money may ultimately never materialize. Yet the changes to the clinical trial process, something long sought by the drug industry, will be set in stone regardless of whether money for the research projects is forthcoming.

Among those changes: Greater prominence will be given to “real world” evidence gathered outside the framework of a randomized, controlled clinical trial, the gold standard for determining whether a drug is safe and effective. Such evidence could be much easier for drug companies to collect.

“The passing of 21st Century Cures Act is a show of extraordinary bipartisan unity after a divisive election that should be celebrated,” said Ellen Sigal, chair of the patient advocacy group Friends of Cancer Research.

Under the Act patient input will be formally incorporated into the FDA’s drug review process.

Funding for the Act will be offset by reductions in some Medicaid payments and through the sale of oil from the Strategic Petroleum Reserve. The White House supports the bill but said earlier it was concerned that draining the Petroleum Reserve “continues a bad precedent of selling off longer term energy security assets to satisfy near term budget scoring needs.”

(Reporting by Toni Clarke in Washington; editing by Leslie Adler and Tom Brown)

Brain Cancer now deadliest for U.S. Children

A general view of Centers for Disease Control and Prevention (CDC) headquarters in Atlanta

By David Beasley

ATLANTA (Reuters) – Brain cancer is now the deadliest form of childhood cancer in the United States, surpassing leukemia as treatment advances have allowed doctors to cure many blood-related cancers, the Centers for Disease Control and Prevention said on Friday.

In 1999, nearly one in three children who died of cancer had leukemia, while brain cancer caused the deaths of one in four.

By 2014, the numbers had reversed, researchers found comparing death rates from pediatric cancers in these years.

“Forms of leukemia that a generation ago were almost universally fatal are now almost universally curable,” said Sally Curtin, an author of the report, in a telephone interview.

Overall, cancer death rates for children dropped 20 percent from 1999, continuing a trend that started in the mid 1970s, according to the National Center for Health Statistics study.

Among 100,000 youth ages one to 19, cancer killed 2.28 in 2014.

Other common sites of fatal childhood cancers included the bone and articular cartilage, thyroid and other endocrine glands and mesothelial and soft tissue. Combined with brain cancer and leukemia, these accounted for 81.6 percent of all childhood cancer deaths in 2014, the report said.

“The declines were broad, across all the age groups, males and females, for both white and black children,” Curtin said. “That in and of itself is noteworthy because so many health outcomes have disparities.”

She noted that brain cancer deaths held stable as leukemia deaths dropped.

In 2014, 445 children died from pediatric leukemia, down from 645 in 1999, the CDC reported.

Deaths from childhood brain cancer, however, increased slightly from 516 in 1999 to 534 in 2014, the study found.

“For pediatric brain tumors in particular, we have not made significant headway at all,” said Katherine Warren, head of pediatric neuro-oncology at the National Cancer Institute.

She said childhood brain cancer is more difficult to treat, in part because the blood-brain barrier protects the central nervous system from toxins. This makes it more difficult to deliver chemotherapy.

“With leukemia, you are giving the therapy directly into the blood and hence to the bone marrow which is exactly where the cancer is,” she said, calling for more research into childhood brain cancers.

“We have learned over the past decade or so that childhood tumors are significantly different from adult tumors,” she added.

(Reporting by David Beasley; Editing by Letitia Stein and Andrew Hay)