FDA approves pill for aggressive type of breast cancer

https://fox8.com/news/health/fda-approves-pill-for-aggressive-type-of-breast-cancer/

WASHINGTON (AP) — U.S. regulators on Friday approved a new drug for an aggressive type of breast cancer that’s spread in the body — including into the brain, where it’s especially tough to treat.

The Food and Drug Administration said Tukysa, a twice-daily pill developed by Seattle Genetics, is for people with what’s known as HER2-positive breast cancer that has spread and resisted multiple other medicines. This type of cancer is driven by an overactive gene that makes too much of the HER2 protein, which promotes cancer growth.

Each year, about 50,000 people in the U.S. are diagnosed with HER2-positive breast cancer. It’s usually curable, but when it spreads it kills most patients. In up to half of them, the cancer reaches the brain, giving that group such a poor prognosis that they have rarely been included in tests of new drugs.

Tukysa, pronounced too-KYE’-sah and also known as tucatinib, works by attacking cancer cells from inside and outside to block production of the HER2 protein.

“This is basically taking the ammunition out of that weapon,” said Dr. Eric Winer, a Dana-Farber Cancer Institute researcher who helped lead the key patient study and consults for Seattle Genetics and other drugmakers.

In that company-funded study, half the 612 participants got Tukysa along with standard cancer drugs Herceptin and Xeloda. The other half got the two standard drugs and a dummy pill.

In the group getting Tukysa, 45% survived at least two years, compared with 27% in the placebo group. Among the participants whose cancer spread to the brain, 25% were alive after a year versus none in the placebo group.

“It’s a significant advance,” said Winer.

Common side effects included diarrhea, fatigue, vomiting and liver function changes.

Tukysa has a list price of $18,500 per month, or roughly $111,000 for an average course of treatment, without insurance. Most patients don’t pay that, and Seattle Genetics plans to offer financial aid.

Tukysa should be available almost immediately.

>>8859193

i don't know how

FDA approves pill for aggressive type of breast cancer

WASHINGTON (AP) — U.S. regulators on Friday approved a new drug for an aggressive type of breast cancer that’s spread in the body — including into the brain, where it’s especially tough to treat.

The Food and Drug Administration said Tukysa, a twice-daily pill developed by Seattle Genetics, is for people with what’s known as HER2-positive breast cancer that has spread and resisted multiple other medicines. This type of cancer is driven by an overactive gene that makes too much of the HER2 protein, which promotes cancer growth.

Each year, about 50,000 people in the U.S. are diagnosed with HER2-positive breast cancer. It’s usually curable, but when it spreads it kills most patients. In up to half of them, the cancer reaches the brain, giving that group such a poor prognosis that they have rarely been included in tests of new drugs.

Tukysa, pronounced too-KYE’-sah and also known as tucatinib, works by attacking cancer cells from inside and outside to block production of the HER2 protein.

“This is basically taking the ammunition out of that weapon,” said Dr. Eric Winer, a Dana-Farber Cancer Institute researcher who helped lead the key patient study and consults for Seattle Genetics and other drugmakers.

In that company-funded study, half the 612 participants got Tukysa along with standard cancer drugs Herceptin and Xeloda. The other half got the two standard drugs and a dummy pill.

In the group getting Tukysa, 45% survived at least two years, compared with 27% in the placebo group. Among the participants whose cancer spread to the brain, 25% were alive after a year versus none in the placebo group.

“It’s a significant advance,” said Winer.

Common side effects included diarrhea, fatigue, vomiting and liver function changes.

Tukysa has a list price of $18,500 per month, or roughly $111,000 for an average course of treatment, without insurance. Most patients don’t pay that, and Seattle Genetics plans to offer financial aid.

Tukysa should be available almost immediately.

https://fox8.com/news/health/fda-approves-pill-for-aggressive-type-of-breast-cancer/

>>8859243

Thank You

BMS gets FDA approval for multiple sclerosis drug, but Covid-19 delays rollout

The Food and Drug Administration has approved a Bristol-Myers Squibb drug for multiple sclerosis that was one of the showcase pipeline candidates in BMS’ $74 billion acquisition of Celgene last year.

BMS said Thursday that the FDA had approved Zeposia (ozanimod) for relapsing MS in adults, including those with clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The New York-based drugmaker said it marked the first new FDA-approved drug since it acquired Celgene.

Despite the fanfare, the company said it would delay the drug’s rollout because due to the healthcare system’s focus on the Covid-19 pandemic, with a growing number of hospitals finding themselves overwhelmed with patients suffering from the disease. Several other companies, including Pfizer, Eli Lilly and BMS itself, have announced plans to pause certain clinical trial operations in order to help health systems cope. Other companies, like bluebird bio and Intercept Pharmaceuticals, have experienced delays in their regulatory dealings with the FDA due to the pandemic.

https://medcitynews.com/2020/03/bms-gets-fda-approval-for-multiple-sclerosis-drug-but-covid-19-delays-rollout/

HERE COME THE CURES!

Cholangiocarcinoma, also known as bile duct cancer, is a type of cancer that forms in the bile ducts. Symptoms of cholangiocarcinoma may include abdominal pain, yellowish skin, weight loss, generalized itching, and fever.

Innovent Biologics Announces FDA Approval of Pemazyre™ (Pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

SUZHOU, China, April 19, 2020 /PRNewswire/ – Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 1801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Pemazyre™ (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. Pemazyre is the first and only FDA-approved treatment for this indication, which was approved under accelerated approval based on overall response rate and duration of response (DOR). Continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial(s).

https://www.prnewswire.com/news-releases/innovent-biologics-announces-fda-approval-of-pemazyre-pemigatinib-as-first-targeted-treatment-for-adults-with-previously-treated-unresectable-locally-advanced-or-metastatic-cholangiocarcinoma-301043183.html

==FDA STATEMENT

Insulin Gains New Pathway to Increased Competition==

March 23, 2020

Statement From:

Principal Deputy Commissioner - Office of the Commissioner

Amy Abernethy MD, PhD.

Director - Center for Drug Evaluation and Research

Janet Woodcock M.D.

Today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients. For the first time, a pathway will be open for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. The availability of safe and effective biosimilar and interchangeable versions of these treatments, including insulin, is expected to increase patient access, adding more choices and potentially reducing costs of these vital therapies.

Biologic drugs, including insulin, treat some of the most serious diseases and conditions. The drugs transitioning today are used in the treatment, diagnosis and prevention of many of these conditions, including diabetes, respiratory distress syndrome, fertility conditions, Cushing’s syndrome, deep vein thrombosis, Gaucher disease and many more. But these life-saving drugs often also contribute significantly to drug costs. Historically, it was more difficult to develop generic versions of these drugs under the Federal Food, Drug and Cosmetic (FD&C) Act due to scientific challenges and limitations on the scope of data that can be relied upon in a generic drug application. This framework contributed to limited competition for these drugs, resulting in fewer choices and higher prices for patients. Today’s transition opens a new pathway for manufacturers to seek FDA approval of and bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition.

https://www.fda.gov/news-events/press-announcements/insulin-gains-new-pathway-increased-competition

==Congress Passes Legislation to Reform Over-the-Counter Drug Regulation

Science-based and streamlined oversight will help improve public health==

Congress gave final approval March 27 to long-needed legislation that will improve the safety of over-the-counter (OTC) medications.

The bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act passed as part of the sweeping Coronavirus Aid, Relief, and Economic Security Act, which President Donald Trump signed later that day. The OTC bill had support from The Pew Charitable Trusts and a diverse group of medical, public health, industry, and consumer interest organizations.

The measure represents the first significant update to federal oversight for OTC products since 1972. Under the regulatory system established nearly 50 years ago, the Food and Drug Administration (FDA) has not been able to quickly respond to safety concerns or keep pace with innovation.

The act’s provisions would help the agency move with greater speed and agility to protect consumers from unsafe drugs and to permit manufacturers to market new products, steps that would benefit Americans who use one or more of the roughly 300,000 OTC drugs on store shelves.

https://www.pewtrusts.org/en/research-and-analysis/articles/2020/03/27/congress-passes-legislation-to-reform-over-the-counter-drug-regulation