FDA approves Stivarga for GIST

Familiar with GIST?
gastrointestinal stromal tumors
GIST

Today, the FDA announced the approval of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.

Learn more here.

FDA approves 2 new drugs at the end of 2012

On the last day of 2012, the FDA approved 2 new drugs:

Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Fulyzaq is distributed by Salix Pharmaceuticals, based in Raleigh, N.C. under license from Napo Pharmaceuticals, Inc.

Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available. Sirturo is manufactured by Janssen Therapeutics, a division of Janssen Products LP, based in Titusville, N.J.

FDA approves weight-management drug Qsymia with a REMS

Here's the press release about a new obesity drug Qsymia (pronounced kyoo-SIM-ee-uh):

FDA approves weight-management drug Qsymia

The U.S. Food and Drug Administration today approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management.

The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

FDA Approves a Fentanyl Sublingual Spray

PHOENIX, AZ--(Marketwire - Jan 5, 2012) - INSYS Therapeutics (PINKSHEETS: NEOL) announces the US Food and Drug Administration approval of its branded breakthrough cancer pain medication, SUBSYS® fentanyl sublingual spray. SUBSYS is a sublingually-administered formulation of fentanyl in a novel delivery device which offers numerous benefits to patients that experience episodes of breakthrough cancer pain. Breakthrough cancer pain is characterized by sudden, often unpredictable, episodes of intense pain which can peak in severity at three to five minutes despite background pain medication. SUBSYS is approved in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

FDA approves Remicade to treat ulcerative colitis in children older than 6 years

The U.S. Food and Drug Administration today approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate response to conventional therapy.

Remicade reduces signs and symptoms of UC and induces and maintains clinical remission in these patients.

UC is a type of inflammatory bowel disease (IBD) that affects the lining of the large intestine (colon) and rectum. Symptoms of UC include abdominal pain, diarrhea, rectal bleeding, weight loss and fever. Between 50,000 and 100,000 children in the United States have IBD; of these, 40 percent have UC.

FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease

The U.S. Food and Drug Administration today approved Arcapta Neohaler (indacaterol inhalation powder) for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.

FDA approves Potiga (ezogabine) to treat seizures in adults

On June 10, Potiga (ezogabine) tablets were approved by the U.S. Food and Drug Administration for use as an add-on medication to treat seizures associated with epilepsy in adults.

Potiga was approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy. Epilepsy is a brain disorder in which there is abnormal or excessive activity of nerve cells in the brain. Partial seizures affect only a limited or localized area of the brain, but can spread to other parts of the brain. Seizures cause a wide range of symptoms, including repetitive limb movements (spasms), unusual behavior, and generalized convulsions with loss of consciousness.

FDA approves Edurant (rilpivirine) for HIV

FDA approves new HIV treatment

The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve).

Edurant belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitor (NNRTI). The drug works by blocking HIV viral replication. Edurant is to be used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the amount of HIV (viral load) in the blood. Edurant is a pill taken once a day with food.

Zytiga (abiraterone) approved for late-stage prostate cancer

The U.S. Food and Drug Administration today approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).

In prostate cancer, the male sex hormone testosterone stimulates prostate tumors to grow. Drugs or surgery are used to reduce testosterone production or to block testosterone’s effects. However, sometimes prostate cancer can continue to grow even when testosterone levels are low. Men with these cancers are said to have castration-resistant prostate cancer.

FDA approves Rituxan (rituximab) to treat Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA)

FDA approves Rituxan to treat two rare disorders

The U.S. Food and Drug Administration today approved Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).

Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints. Both of these diseases affect people of all ages and ethnicities, and both genders. The causes of these disorders are unknown, and both are considered orphan diseases because they each affect less than 200,000 people in the United States.

“This new indication for Rituxan provides the first approved therapy for these two orphan diseases,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

FDA approves Yervoy (ipilimumab) to treat melanoma

FDA approves new treatment for a type of late-stage skin cancer
Melanoma patients lived longer with treatment

The U.S. Food and Drug Administration today approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in the United States during 2010 and about 8,700 people died from the disease, according to the National Cancer Institute.

“Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. "Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment."

First new lupus drug approved in 56 years

I still remember the first patient with lupus I saw as an early medical student. The patient had a classic "butterfly rash" and was miserable.  Systemic lupus erythematosus (SLE) is a chronic inflammatory disease of unknown cause that can affect the skin, joints, kidneys, lungs, nervous system, serous membranes and/or other organs of the body. It's been over 50 years since a new drug has been approved for the treatment of lupus!

FDA approves Benlysta to treat lupus

First new lupus drug approved in 56 years

The U.S. Food and Drug Administration today approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.

Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.

Prior to Benlysta, FDA last approved drugs to treat lupus, Plaquenil (hydroxychloroquine) and corticosteroids, in 1955. Aspirin was approved to treat lupus in 1948.

FDA approves Corifact for congenital Factor XIII Deficiency

FDA approves product to prevent bleeding in people with rare genetic defect
Corifact is 1st treatment for congenital Factor XIII Deficiency

The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

Patients with congenital Factor XIII deficiency don’t make enough Factor XIII, a substance that circulates in the blood and is important for normal clotting. Without treatment, people with the condition are at risk for life-threatening bleeding.

FDA Approved Drugs for Oncology in 2010

As we look back at the year, it's interesting to see how many new oncology drugs have been approved this year. According to CenterWatch, we had the following new drugs (or new drug indications) in oncology:

• Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved November 2010
• Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October 2010
• Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June 2010
• Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer, Approved May 2010
• Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with bone metastases from solid tumors, Approved November 2010
• Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010

Several of these drugs are not new, but they received new indications. For instance, Herceptin has been around for the treatment of breast cancer, but it recently received a new indication for the treatment of gastric cancer. If we review the FDA website, we see that several other oncology drugs received accelerated approval, a few drugs got pulled from the market, and that non-drug technologies were approved in oncology. One example of a non-drug technology is hexaminolevulinate hydrochloride (Cysview for Intravesical Solution, Photocure ASA), as an optical imaging agent for use in combination with the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System for cystoscopic detection of non-muscle invasive papillary cancer of the bladder for patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. (May 28, 2010)

So what will 2011 look like in oncology? I'm sure we'll see several new targeted therapies, vaccines and other novel drugs used to treat and prevent cancer. It should get more interesting as we get more involved with genomics and personalized medicine in the area of oncology.

FDA approves Halaven (eribulin mesylate) for the treatment of metastatic breast cancer

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

Read more on the FDA website.

FDA approves Egrifta to treat Lipodystrophy in HIV patients

The FDA announced this yesterday: "FDA approves Egrifta to treat Lipodystrophy in HIV patients"

The U.S. Food and Drug Administration today approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretroviral drugs used to treat HIV.

Egrifta was developed by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Mass.-based EMD Serono.

Read more here.

Afinitor receives FDA approval for a new indication (now approved to treat rare genetic disorder)

The U.S. Food and Drug Administration approved the cancer drug Afinitor (everolimus) on Friday to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), a rare genetic disorder. This approval was for treatments of SEGA that can not be treated with surgery.

You can read more here.

2 new drugs approved by the FDA: Teflaro (ceftaroline) and Latuda (lurasidone)

The FDA recently approved 2 new drugs:

• Teflaro (ceftaroline fosamil), an injectable antibiotic to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA). Teflaro is marketed by New York City-based Forest Laboratories.
• Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia. Latuda is manufactured by Sunovion Pharmaceuticals Inc. of Fort Lee, N.J.

Read about these drugs here on the FDA website.

FDA approves Pradaxa (dabigatran etexilate) to prevent stroke in people with atrial fibrillation

We now have a new class of oral anticoagulation medications on the market. Here's the news from the FDA:

The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

Pradaxa is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting. The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.

Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn., will be available in 75 milligram and 150 milligram capsules.

Read more here.

FDA approves Vivitrol to treat opioid-dependent patients

The U.S. Food and Drug Administration today approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.

Vivitrol is an extended-release formulation of naltrexone administered by intramuscular injection once a month. Naltrexone works to block opioid receptors in the brain. It blocks the effects of drugs like morphine, heroin, and other opioids. It was approved to treat alcohol dependence in 2006.

You can read more here.