Pfizer Receives Expanded FDA Approval For Ibrance (palbociclib) In HR , HER2- Metastatic Breast Cancer

In continuation of my updates on palbociclib

Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of Ibrance (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy. Now Ibrance also is approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.1 Pfizer’s supplemental New Drug Application (sNDA) for Ibrance was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs based on results from the Phase 3 PALOMA-3 trial in pre-, peri- and post-menopausal women with HR+, HER2- metastatic breast cancer whose disease progressed on or after prior endocrine therapy in the adjuvant or metastatic setting.

Ibrance first was approved in February 2015 and also is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with letrozole as initial endocrine-based therapy in postmenopausal women.1 The indication in combination with letrozole is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1 The confirmatory Phase 3 trial, PALOMA-2, is fully enrolled.

Ibrance is the first and only cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor approved by the FDA.

Pfizer Receives Expanded FDA Approval For Ibrance (palbociclib) In HR , HER2- Metastatic Breast Cancer

FDA-approved Alzheimer's medications may help people quit smoking

Despite several safe drug therapies available to help smokers quit, three-quarters report relapsing within six months of a quit attempt. University of Pennsylvania researchers Rebecca Ashare and Heath Schmidt saw potential for a permanent cessation solution in a class of FDA-approved medications used to improve cognitive impairments from Alzheimer's disease.

In a study consisting of a rat trial and a human trial, Ashare and Schmidt studied the effects of two acetylcholinesterase inhibitors, or AChEIs, called galantamine and donepezil on overall nicotine intake. The rat component showed that pretreating the rodents with an AChEI decreased their nicotine consumption. Consistent with these effects, clinical trial participants taking the AChEI, not the placebo, smoked 2.3 fewer cigarettes daily, a 12 percent decrease, and noted feeling less satisfied with the cigarettes they did smoke.

 (Galantamine )  (Donepezil) 

"We're very interested in screening potential efficacy of anti-addiction medications in our models," said Schmidt, a professor in Penn's School of Nursing and Perelman School of Medicine. "For this study, we looked at potential smoking-cessation medications."

The research itself took a translational approach, what Ashare, a professor in Penn Medicine's psychiatry department, calls bi-directional. In other words, the preclinical data informed the clinical study and vice versa.

At Penn's Center for Interdisciplinary Research on Nicotine Addiction, work on smoking cessation has been ongoing since 2001. Specifically, research from Caryn Lerman, CIRNA's director and the Mary W. Calkins Professor in Psychiatry, concluded that ...

FDA-approved Alzheimer's medications may help people quit smoking

No evidence found linking anti-nausea drug to birth defects

No evidence found linking anti-nausea drug to birth defects: No evidence has been found to link the anti-nausea drug Zofran to an increased risk of birth defects. In fact, women with the condition who took Zofran reported fewer miscarriages and pregnancy terminations and higher live birth rates than women with extreme morning sickness who did not take the drug.

Novartis receives FDA Breakthrough Therapy designation for PKC412 (midostaurin)

Novartis announced today that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to PKC412 (midostaurin). PKC412 (midostaurin) is an investigational treatment for adults with newly-diagnosed AML who are FLT3 mutation-positive, as detected by an FDA-approved test, and who are eligible to receive standard induction and consolidation chemotherapy.

The Breakthrough Therapy designation for PKC412 (midostaurin) is primarily based upon the positive results from the Phase III RATIFY (CALGB 10603) clinical trial. This study was conducted in partnership with the Alliance for Clinical Trials in Oncology and presented during a plenary session at the 57th American Society of Hematology (ASH) Annual Meeting.

Patients who received PKC412 (midostaurin) and standard induction and consolidation chemotherapy experienced a significant improvement in overall survival (OS) (hazard ratio = 0.77, P = 0.0074) compared to those who received standard induction and consolidation chemotherapy alone. The median OS for patients in the PKC412 (midostaurin) treatment group was 74.7 months (95% confidence interval [CI]: 31.7, not attained), versus 25.6 months (95% CI: 18.6, 42.9) for patients in the placebo group. No statistically significant differences were observed in the overall rate of grade 3 or higher hematologic and non-hematologic adverse events in the PKC412 (midostaurin) treatment group versus the placebo group. A total of 37 deaths were reported, with no difference in treatment-related deaths observed between groups.

"For more than 25 years, medical developments have been limited for AML patients and the chemotherapy treatment strategy has essentially remained unchanged," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "We look forward to working closely with the FDA to bring PKC412 (midostaurin), the first potential AML targeted therapy, to patients as quickly as possible."

Novartis receives FDA Breakthrough Therapy designation for PKC412 (midostaurin)

Lenalidomide trials show potential for expanding lymphoma, leukaemia indications

Positive findings from two clinical trials have been published for the immunomodulatory agent lenalidomide in patients with heavily pretreated mantle cell lymphoma, and in adults with T-cell leukaemia-lymphoma or peripheral T-cell lymphoma.

The results of the phase II MCL-002 (SPRINT) study suggest that, compared with an investigator's choice of treatment, lenalidomide 25 mg/day on days 1-21 of a 28-day cycle significantly improved progression-free survival (PFS) in patients with relapsed or refractory mantle cell lymphoma who were ineligible for intensive chemotherapy or stem cell transplantation.

After a median of 15.9 months, the 170 lenalidomide-treated patients had a median PFS of 8.7 months compared with 5.2 months in the 84 patients who were treated with single-agent rituximab, gemcitabine, fludarabine, chlorambucil or cytarabine, giving a hazard ratio (HR) of 0.61.

Lenalidomide trials show potential for expanding lymphoma, leukaemia indications

FDA Approves Zepatier (elbasvir and grazoprevir) for Chronic Hepatitis C Genotypes 1 and 4

 (Elbasvir) 

 (Grazoprevir)

The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop cirrhosis over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, approximately 3 million Americans are infected with HCV, of which genotype 1 is the most common and genotype 4 is one of the least common.

“Today’s approval provides another oral treatment option for patients with genotypes 1 and 4 HCV infections without requiring use of interferon,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

FDA Approves Zepatier (elbasvir and grazoprevir) for Chronic Hepatitis C Genotypes 1 and 4

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

In continuation of my update on daclatasvir

Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response (SVR) rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ribavirin. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir with or without (+/-) ribavirin for 12 weeks.

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

St. Renatus, LLC Announces FDA Approval of Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray for Use in Dentistry

St. Renatus, LLC, a privately held company based in Fort Collins, Colorado,  announced the U.S. Food and Drug Administration (FDA) approval on June 29, 2016 for its first product, a new dental anesthetic, Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray. This is the first product that allows for dental anesthesia to be administered through a nasal spray without using a needle.

 Tetracaine           Oxymetazoline

"For more than 100 years, the dental industry has delivered dental anesthesia using a needle injection. Now, through the efforts of a dedicated team, we have developed a revolutionary needle-free method for delivering pulpal anesthesia," said Steve Merrick, St. Renatus' CEO.

Kovanaze is intended for use in dentistry as a topical anesthetic, delivered in the nasal cavity to achieve pulpal (tooth nerve) anesthesia for the restorative treatment of teeth. Like traditional dental injections, this product delivers a local dental anesthetic but without the needle.

Kovanaze is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.

FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients With Advanced Liver Disease

In continuation of my update on Harvoni (ledipasvir/sofosbuvir)

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in combination with ribavirin (RBV) for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. Harvoni is now approved for use in a broader range of patient populations, including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis..

FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients With Advanced Liver Disease

Arbor Pharmaceuticals Announces FDA Approval of Cetylev

Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Cetylev (acetylcysteine effervescent tablets for oral solution).  

(acetylcysteine)

Cetylev is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion. Acetaminophen overdose is the most common poisoning reported to emergency rooms in the United States. According to the American Association of Poison Control Centers there were 73,347 reported acetaminophen exposures in 2014 which resulted in 108 deaths.

Cetylev will be available in ready to use effervescent tablets intended to be mixed with water, resulting in a pleasant lemon-mint tasting solution. Currently, acetylcysteine solution is available in vials intended for inhalation which pharmacists typically mix with a diet cola for ingestion orally. It is also available in an intravenous dosage form which requires that patients be admitted into the hospital.

"For patients with acetaminophen overdose, it is critically important to administer acetylcysteine as quickly as possible to reverse or reduce potential fatal damage to the liver. Emergency rooms, ambulances and pharmacies will have a ready to use dosage form of acetylcysteine that can be administered quickly," said Ed Schutter, President and CEO of Arbor. "Cetylev adds to our growing portfolio of now nineteen different approved prescription products that may help to improve the lives of our patients."

Arbor Pharmaceuticals Announces FDA Approval of Cetylev