Month: March 2018

FDA approved abiraterone acetate (Zytiga) in combination with prednisone for patients with metastatic high-risk castration-sensitive disease.

The first-line treatment of patients with metastatic castration-sensitive prostate cancer has undergone a significant number of changes in the last few years. Most recently, the FDA approved abiraterone acetate (Zytiga) in combination with prednisone for patients with metastatic high-risk castration-sensitive disease.

This approval of abiraterone was based on findings from the phase III LATITUDE trial. In the study, there was a 38% reduction in the risk of death with the addition of abiraterone and prednisone to androgen deprivation therapy (ADT) compared with ADT alone.

Another pivotal trial of abiraterone in prostate cancer was STAMPEDE. This trial showed that the addition of abiraterone to standard initial therapy lowered the relative risk of death by 37% and improved progression-free survival by 71% in both nonmetastatic and metastatic patients with high-risk hormone-naïve disease.

Although there is much excitement with androgen receptor (AR)-directed agents, docetaxel remains a staple of treatment. James Luke Godwin, MD, says that clinicians have now reached an interesting decision point on how to treat their patients in the frontline setting moving forward.


Anticancer Agent LENVIMA Approved for Additional Indication of Unresectable Hepatocellular Carcinoma (HCC) in Japan

This is the first approval worldwide for LENVIMA for the indication of unresectable HCC and the first new systemic therapy to be approved in Japan for the front-line treatment of HCC in approximately 10 years. Additionally, this is the first regulatory approval for LENVIMA under the global strategic collaboration agreement executed in March 2018 between Eisai and Merck & Co., Inc., Kenilworth N.J., U.S.A. for the co-development and co-commercialization of LENVIMA*.

Tasigna approved for children with rare form of leukemia

Novartis announced the FDA has expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.

In the U.S., Tasigna is now indicated for the treatment of adult and pediatric patients one year of age or older with newly diagnosed Ph+ CML-CP. Tasigna is also indicated for the treatment of pediatric patients one year of age or older with Ph+ CML-CP resistant or intolerant to prior tyrosine kinase inhibitor therapy, as well as adult patients with Ph+ CML in chronic phase and accelerated phase, resistant or intolerant to prior therapy that included imatinib.

This approval is the latest in a series of regulatory milestones that broadens the understanding and clinical use of Tasigna.

CML is a type of blood cancer where the body produces malignant white blood cells. Almost all patients with CML have an abnormality known as the “Philadelphia chromosome,” which produces a protein called BCR-ABL. This protein aids the proliferation of malignant white blood cells in affected patients. Worldwide, CML accounts for approximately 3% of newly diagnosed childhood leukemia.


Studies Support Shortened, 8-Week HCV Treatment

Evidence supporting the FDA-approved option to shorten treatment of hepatitis C virus (HCV) genotypes 1 and 3 infection without cirrhosis with glecaprevir-pibrentasvir (Mavyret) from 12 weeks to 8 was drawn from two large multicenter trials involving over 1200 patients.

Analysis of data from the phase 3, open-label trials comparing 8 and 12-week regimens was recently consolidated in a report published by Stefan Zeuzem, MD, Professor of Medicine and Chief, Department of Medicine I, Goethe University Hospital, Frankfurt, Germany and colleagues.

“Although the current standard-of-care treatments for patients without cirrhosis who are infected with HCV genotype 1 or genotype 3 result in high rates of sustained virologic response (SVR), patients could benefit from shorter-duration treatment options that maintain high efficacy irrespective of HCV genotype,” Zeuzem and colleagues noted.

The ENDURANCE-1 trial evaluated the efficacy and safety of the fixed dose combination of glecaprevir-pibrentasvir (GLE-PIB) in HCV genotype 1-infected patients, including those with human immunodeficiency virus type 1 (HIV-1) co-infection. Patients were randomized in a 1:1 ratio to receive GLE-PIB for either 8 or 12 weeks.

The ENDURANCE-3 trial compared efficacy and safety of GLE-PIB to treatment with sofosbuvir (Sovaldi) dosed with daclatasvir (Daklinza) in treatment-naive patients with genotype 3 infection. Initially, patients were randomized in a 2:1 ratio to receive either GLE-PIB (3 tablets yielding 300mg glecaprevir and 120mg pibrentasvir) or the combination of 400mg of sofosbuvir with 60mg daclatasvir daily for 12 weeks. After the availability of preliminary data supporting the efficacy of an 8-week regimen, the protocol was amended to include a third group for 8 weeks of treatment with GLE-PIB.

“Until recently, there were no approved treatment regimens with a duration of less than 12 weeks for patients with HCV genotype 3 infection,” said Zeuzem and colleagues, “and 8-week treatment options for patients with genotype 1 infection were limited according to virus subtype, treatment history, fibrosis stage, or baseline viral load.”

Zeuzem and colleagues reported that the SVR at 12 weeks was 99.1% among genotype 1-infected patients receiving 8 weeks of GLE-PIB, compared with 99.7% treated for 12 weeks. In patients with genotype-3 infection treated for 12 weeks, 95% receiving GLE-PIB and 97% receiving sofosbuvir/daclatasvir attained SVR. Ninety-five percent of the patients with genotype 3 infection treated with 8 weeks of GLE-PIB also attained SVR measured at 12 weeks.


Newer drugs make hepatitis C-positive kidneys safe for transplant

People who received kidneys from donors infected with hepatitis C did not become ill with the virus, thanks to treatment with newer drugs that can cure the disease, a small study reports.

Ten patients not previously infected with hepatitis C took doses of powerful antiviral medications before and after receiving the transplants. None of the patients developed chronic infections, researchers report online March 6 in the Annals of Internal Medicine. The finding could help make more kidneys available for transplants.

“If this increases access to transplantation, then this is a great benefit,” says Jay Fishman, a transplant infectious disease specialist at Massachusetts General Hospital in Boston.

As of January 2016, more than 100,000 people in the United States were awaiting transplants, according to the National Kidney Foundation. In many areas, patients can linger on waiting lists for more than five years. In 2014, there were about 17,000 kidney transplants in the country, and nearly 4,800 people died while waiting.

Traditionally, organs from donors with hepatitis C were offered to recipients already infected with the disease, because the virus could be transmitted during a transplant. And one of the main drugs previously used to treat the infectious liver disease was not very effective and had many side effects, including the possibility of transplant rejection. But in the last several years, more effective drugs, called direct-acting antivirals, have been approved for use. These drugs cure hepatitis C in more than 95 percent of patients.

At the same time, more hepatitis C-positive organs have become available. The increase is likely due to rising numbers of overdose deaths from opioids (SN: 6/10/17, p. 22), says Christine Durand, a transplant infectious disease specialist at Johns Hopkins School of Medicine.


Lenalid (Generic of Revlimid)

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Myhep LVIR is the combination Ledipasvir/Sofosbuvir

Mylan Pharma, has launched Ledipasvir 90 mg/Sofosbuvir 400 mg tablets under the brand name MyHep LVIR™ in India.

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Velpanat (Velpatasvir and Sofosbuvir)

Velpanat is the combination medicine of Velpatasvir and Sofosbuvir which is manufactured by NATCO Pharma and available as 400 mg Sofosbuvir and 100 mg Velpatasvir as 28 Tablets in one bottle and it is used in the treatment of Chronic Hepatitis C.

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HepBest For Hepatitis B

According to WHO more than 2 billion people worldwide are contaminated with Hepatitis B Virus (HBV) and 240 million people have chronic liver Infection.

Mylan Pharmaceutical launched HepBest 25 mg (Tenofovir alafenamide), this is the first drug in eight years to be approved for HBV in India.
HepBest is the prescription drug used to treat Chronic Hepatitis B Virus in Adults with stable liver Disease. Symptoms of a hepatitis B Infection may include: Tiredness/Fatigue, Joint Pain, Stomach Pain, Fever, Vomiting and Nausea, Loss of Appetite, Jaundice (Yellowish eyes and skin), light colored Stools/Dark Urine.

You must take HepBest exactly how your doctor tells you. Generally, take one small tablets once a day with food. Do not stop taking HepBest unless your doctor tells you to. If you stop taking your medicine, your HBV infection could get worse (flare-up).

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