|
|
|
|
|
|
|
|
FDA abstract
On December 19, 2014, the FDA approved olaparib capsules (Lynparza™, AstraZeneca) for the treatment of patients with deleterious
or suspected deleterious germline BRCA-mutated (gBRCAm)
advanced ovarian cancer who have been treated with three or more prior
lines of chemotherapy. The BRACAnalysis CDx™ (Myriad
Genetic Laboratories, Inc.) was approved
concurrently. An international, multicenter, single-arm trial enrolled
137 patients
with measurable, gBRCAm-associated ovarian
cancer treated with three or more prior lines of chemotherapy. Patients
received olaparib at a dose of
400 mg by mouth daily until disease progression or
unacceptable toxicity. The overall response rate (ORR) was 34% with
median
response duration of 7.9 months in this cohort. The
most common adverse reactions (≥20%) in patients treated with olaparib
were anemia, nausea, fatigue (including asthenia),
vomiting, diarrhea, dysgeusia, dyspepsia, headache, decreased appetite,
nasopharyngitis/pharyngitis/URI, cough,
arthralgia/musculoskeletal pain, myalgia, back pain, dermatitis/rash and
abdominal
pain/discomfort. Myelodysplatic syndrome and/or
acute myeloid leukemia occurred in 2% of the patients enrolled on this
trial.
0 comments :
Post a Comment
Your comments?
Note: Only a member of this blog may post a comment.