See What FDA Approved


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Olaparib, PARP Inhibitor has been approved by FDA for first-line maintenance setting. Olaparib got approval from phase-III Solo trial where it lowered disease progression up to 70% whereas patients didn’t get relief from Placebo or Chemotherapy. Though Olaparib isn’t able to attain progression-free survival like a placebo.

It’s the first of its kind. It’s a treatment for BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. These might have responded to chemotherapy or not.

BRCA Cdx analysis would help to identify whether these patients are eligible for olaparib therapy or not.

Pembrolizumab has got approval by FDA for Merkel cell carcinoma. Phase-II CITN-09/KEYNOTE-054 trial showed the effectiveness of pembrolizumab in patients who did not respond to systemic therapy. After different tests on patients, it was revealed that pembrolizumab could give PFS of 16.8 months while OS hasn’t achieved yet.

Romioplostim has been approved by FDA for immune thrombocytopenia in patients who showed zero response to corticosteroids, immunoglobulins or splenectomy. In placebo-controlled romioplostim trials, 20% and 71% was an overall platelet response rate respectively.

Trastuzumab is biosimilar to Herzuma. These are used in the treatment of patients with breast cancer along HER-2 overexpression. The biosimilar provided a long-term disease-free survival to the patients and an overall survival similar to Herzuma. Trastuzumab has won FDA approval.

Recently European Commission has approved Pembrolizumab for patients with resected stage-III disease with lymph node involvement. It was compared with placebo and provided recurrence-free survival of 72% as compared to 54% in cases of placebo for 18 months, regardless mutations of PD-L1 or BRAF.