publication date: Jan. 2, 2015
20150102 - Jan. 2, 2015
December 2014PDF

 Drugs and Targets

FDA Grants Approvals to Lynparza, Blincyto, Xgeva, Gardasil 9 and Cyramza

FDA approved Lynparza (olaparib) capsules as monotherapy for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. FDA also approved a molecular companion diagnostic.

The approval of Lynparza, sponsored by AstraZeneca Pharmaceuticals LP, is based on objective response rate from the international single-arm trial in patients with deleterious or suspected deleterious gBRCAm advanced cancers. The trial enrolled 137 patients with measurable, gBRCAm-associated ovarian cancer treated with three or more prior lines of chemotherapy.

 Leukemia

Tasigna Shows High Response, PFS Benefit Compared to Gleevec in Phase III CML Study

Six-year results from the randomized phase III ENESTnd study continued to show higher rates of early, deep and sustained molecular responses when using Tasigna (nilotinib) compared to Gleevec (imatinib mesylate) in newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia. 

The data also demonstrated a reduced risk of progression compared to Gleevec. The update was presented at the annual meeting of the American Society of Hematology in San Francisco.

The difference in the rates of MR4.5 showed continued improvement for both Tasigna 300 mg and 400 mg twice-daily arms compared to Gleevec (MR4.5: 6-10 percent difference by one year, 22-23 percent difference by six years). MR4.5 represents an extremely low level of detectable BCR-ABL protein, the cause of Ph+ CML (measured in the blood at 0.0032 percent or less on a standardized international scale). 

Also:

 Breast Cancer

Ovarian Suppression Treatment Plus Tamoxifen Can Lower Recurrence Risk

Premenopausal women who received ovarian suppression treatment along with tamoxifen had a lower risk of breast cancer recurrence, according to data from a clinical trial sponsored and supported by NCI.

The study showed that suppressing ovarian function reduced breast cancer recurrence in premenopausal women receiving the drug tamoxifen after surgery for early-stage breast cancer. 

The phase III trial, SOFT (Suppression of Ovarian Function Trial), used either monthly injections of the drug triptorelin, surgical removal of both ovaries, or radiation of the ovaries as methods of ovarian suppression in women with hormone receptor-positive breast cancer. 

 Lymphoma
Phase II Imbruvica Trial Shows 47% of MCL Patients Alive at 27-Month Follow-up
 Gastric Cancer
Amgen Cancels Phase III Trials of Rilotumumab
 NCI CTEP-Approved Trials for the Month of December

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