February 22, 2018

Cancer-killing drug approved, but will you be able to afford it?

31 August 2017, 01:45 | Rex Hubbard

The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel Switzerland

The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel Switzerland

Tisagenlecleucel (Kymriah) is a personalized genetically-modified autologous T cell immunotherapy created to use a patient's own T cells to target and kill leukemia cells with CD19 antigens on the surface, according to a press release. In June, a clinical trial in China showed promise in treating another blood cancer, multiple myeloma, using reprogrammed T-cells in much the same way Kymriah does.

In its announcement, Novartis said it plans to make additional filings for Kymriah in the USA and EU this year, including applications with the FDA and European Medicines Agency for the treatment of adult patients with r/r diffuse large B-cell lymphoma.

ALL is an aggressive cancer that affects some 3,100 people aged 20 and younger each year in the United States, making it the nation's most common childhood cancer.

Most patients with ALL recover through other treatments such as radiation, chemotherapy and stem cells.

This type of immunotherapy, known as a CAR-T cell therapy, was known by the term CTL019 until now.

"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", FDA Commissioner Dr. Scott Gottlieb said in an FDA news release. It's these patients for whom Kymriah is intended. Once modified, the cells are infused back into the patient to kill the cancer cells.

Dhaka Test: Australia in trouble after Day 2 against Bangladesh
Yet Lyon's landmark day was soured as he went on to make a duck after being sent in with Australia two down. Tamim Iqbal was set on 30, with nightwatchman Taijul Islam yet to score.

The FDA based its decision on a clinical trial involving 63 patients with B-cell ALL.

However, Kymriah comes with the potential for severe side effects. Kymriah will carry a boxed warning for cytokine release syndrome, a potentially lethal systemic response to the activation and proliferation of CAR-T cells, causing high fever and potential for neurological problems.

Kymriah has a $475,000 price tag; however, patients who do not respond within a month of treatment will not be charged, according to Novartis. The drug's maker, Novartis, is required as a condition of approval to conduct a longer-term study of Kymriah's use, the agency said. Researchers hope that this will lead to further CAR-T treatments that can fight more complicated cancers such as pancreatic, breast, and brain cancer.

Other genetic therapies for cancer are also in the research pipeline.

Novartis plans additional filings for Kymriah in the USA and EU later this year, including applications with the FDA and European Medicines Agency, for the treatment of adult patients with r/r diffuse large B-cell lymphoma (DLBCL). "It's not a one-shot deal".

Other News

Trending Now

North Korea uses multiple-rocket launcher to test missiles
But barely a day later after Tillerson spoke, photographs emerged showing Kim inspecting missile and missile-fuel components. It is also believed to be developing a solid-fuel missile that could be used for submarine launches.

Thousands Flee Myanmar As Fresh Violence Claims At Least 104 Lives
Rohingya leaders say 8,000 to 9,000 Rohingya have entered Bangladesh since a fresh wave of violence broke out in Rakhine last Thursday.

Sony channel warns Kapil Sharma after Baadshaho team left the sets
The shoot was cancelled indeed, confirmed the Shivaay actor in an interview to IANS, saying: "We left because he hadn't reached". But now, Emraan says that he is only focusing on good stories and he did not want to do films just for the sake of doing it.

Total eclipse gives Americans thrills
The moon continued across the sun before departing around 3:52 p.m., for a total eclipse time of around 2 hours and 40 minutes. He said the math is very complicated, but it can be figured out precisely, with the next eclipse to take place in April, 2024.

MI and Florida unveil bright color rush uniforms for season opener
When asked if it would be a game-time decision on who starts, McElwain said, "We've got a plan". McElwain was asked about the approach Harbaugh has taken toward the roster matter.

Aston Martin CEO: We'll Hybrid Everything By The Mid-2020s
Palmer revealed that roughly one quarter of Aston Martin's lineup will have a battery option by the end of the 2020s. But there will be more mainstream (if such a word can apply) hybrid and battery EV Aston Martins coming, too.

Houston Church Denies Rumors Regarding Closing Doors on Storm Victims
Lakewood Church is defending itself after receiving social media criticism for not opening to residents displaced by flooding. The Washington Post also published a photo which appears to show significant flooding outside the church.

How to Watch the 'Game of Thrones' Season 7 Finale
You can choose the channel depending on your needs from Sky Sports, Sky Cinema, and others on a daily, weekly, or monthly basis. On August 10 Proofpoint detected malicious email messages (Figure 1) purporting to contain unreleased Game of Thrones content.

Lebanon army declares pause in offensive against ISIL
Later on Sunday, Foreign Minister Jebran Bassil congratulated the Lebanese army on its victory against terrorism. The two sides say they have driven the militants from most of the border region.

Hacked? Nude pics of Justin Bieber reportedly posted to Selena Gomez's Instagram
On Monday Selena Gomez's Instagram page was seized, and several naked photos of ex-boyfriend Justin were posted shortly after. Order was restored a short while later with her account returning to normal and no evidence that the hack had even happened.