FDA approves new option for cancer patients

Vitrakvi is the first medication developed specifically to target tumors based on gene mutations, not their location in the body.

Posted: Nov 29, 2018 10:26 AM
Updated: Nov 29, 2018 10:44 AM

The US Food and Drug Administration approved two cancer treatments, Vitrakvi and Xospata, this week after expedited reviews.

Vitrakvi, approved Monday, is "a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker)."

The FDA said in a statement that it is the second approved cancer treatment that is based on a tumor biomarker instead of the place in the body where the tumor originated.

Vitrakvi will be used for the treatment of solid tumors that have an NTRK (neurotrophic receptor tyrosine kinase) gene fusion that do not have a known resistance mutation, that are not metastatic or where surgical removal is likely to lead to severe morbidity, and that have no alternative treatments or have progressed after treatments.

NTRK genes are rare but occur in many types of cancer, the FDA said, such as mammary analogue secretory carcinoma and infantile fibrosarcoma.

Xospata tablets, approved Wednesday, are for the "treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation," according to the FDA.

Alongside the tablets, the agency also approved a diagnostic to detect the mutation.

"Approximately 25 to 30 percent of patients with AML have a mutation in the FLT3 gene. These mutations are associated with a particularly aggressive form of the disease and a higher risk of relapse," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in the statement.

AML is a rapidly progressing cancer that affects the numbers of normal blood cells and calls for continuous transfusions, the FDA said.

Both treatments were granted Priority Review designation.

Priority Review, established in 1992, means the FDA aims to review the drug or treatment within six months, opposed to 10 months for a standard review.

"A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications," the FDA says.

Both treatments also received orphan drug designation, a status granted to drugs for rare diseases or conditions.

West Lafayette
Clear
40° wxIcon
Hi: 46° Lo: 30°
Feels Like: 40°
Kokomo
Clear
37° wxIcon
Hi: 46° Lo: 27°
Feels Like: 33°
Rensselaer
Clear
36° wxIcon
Hi: 43° Lo: 28°
Feels Like: 32°
Fowler
Clear
40° wxIcon
Hi: 45° Lo: 30°
Feels Like: 40°
Williamsport
Clear
36° wxIcon
Hi: 46° Lo: 30°
Feels Like: 29°
Crawfordsville
Clear
37° wxIcon
Hi: 46° Lo: 31°
Feels Like: 33°
Frankfort
Partly Cloudy
37° wxIcon
Hi: 45° Lo: 29°
Feels Like: 33°
Delphi
Clear
37° wxIcon
Hi: 46° Lo: 29°
Feels Like: 31°
Monticello
Clear
36° wxIcon
Hi: 46° Lo: 31°
Feels Like: 32°
Logansport
Clear
34° wxIcon
Hi: 44° Lo: 28°
Feels Like: 29°
Tracking rain, thunder, strong winds & snow...
WLFI Temps
WLFI Planner

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 1118335

Reported Deaths: 17712
CountyCasesDeaths
Marion1455892240
Lake724831254
Allen67063882
Hamilton51060487
St. Joseph49820649
Elkhart40268546
Vanderburgh34714497
Tippecanoe30808276
Johnson27696467
Hendricks26313385
Porter25657386
Madison21131455
Clark20238279
Vigo19059309
LaPorte17192261
Howard16770314
Delaware16761303
Monroe16628220
Kosciusko14293167
Hancock13113186
Bartholomew12983190
Warrick12210190
Wayne12090269
Floyd12011226
Grant11998245
Morgan10409192
Boone9869124
Noble9316122
Henry9177169
Marshall9152147
Dearborn8970100
Dubois8835140
Shelby8281130
Cass8167128
Lawrence8057185
DeKalb7817109
Jackson770793
Huntington7661115
Gibson7102118
Montgomery7101123
Harrison6954100
Knox6915116
Steuben669089
Whitley659660
Miami6595113
Putnam645085
Clinton627179
Wabash6221111
Jasper613192
Jefferson5856105
Ripley557294
Adams542281
Daviess5076117
Scott491580
Wells4836105
White478469
Greene4701101
Clay464662
Decatur4611110
Fayette452496
Jennings452067
LaGrange427491
Posey410044
Randolph3944107
Washington390956
Fountain375964
Fulton364874
Spencer362247
Starke355574
Owen353577
Sullivan348555
Orange331372
Jay331050
Rush309533
Carroll296239
Franklin292744
Perry290553
Vermillion283658
Tipton251167
Parke250130
Pike248644
Blackford222144
Pulaski210359
Newton182452
Brown177550
Crawford169129
Benton168417
Martin152120
Switzerland147612
Warren135816
Union122616
Ohio92413
Unassigned0595

COVID-19 Important links and resources

As the spread of COVID-19, or as it's more commonly known as the coronavirus continues, this page will serve as your one-stop for the resources you need to stay informed and to keep you and your family safe. CLICK HERE

Closings related to the prevention of the COVID-19 can be found on our Closings page.

Community Events