New drug for ovarian cancer! Clovis company PARP inhibitor Rubraca single drug maintenance treatment for relapsed ovarian cancer by the European Union CHM: .

Clovis Oncology recently announced that the European Medicines Agency (EMA) Committee on Human Pharmaceutical Products (CHMP) has issued a positive opinion recommending the approval of rucaparib, an additional adaptive drug targeted at cancer, as a single-drug therapy for adults with relapsed (full or partially relieved) relapsed epithelial ovarian, fallopian and primary peritonal cancer. The European Commission (EC) usually takes CHMP's advice when making final review decisions and is expected to approve them in the first quarter of 2019. As recently as the end of May, Rubraca was approved by the European Union as the first PARP inhibitor to be used as a single drug therapy to treat women with relapsed ovarian cancer.
positive opinion of CHMP is based on data from Phase III clinical study ARIEL3. The study, a randomized, double-blind, placebo-controlled study conducted in patients with platinum-sensitive ovarian cancer who underwent full or partial remission with platinum chemotherapy, assessed whether Rubraca's use as a maintenance therapy relative to a placebo extended disease control time. The study included 564 patients with high-level epithalized ovaries, fallopian tubes, or primary peritiotic cancer who had previously received at least two platinum-containing chemotherapy options, were sensitive to the penultimate platinum-containing treatment, and received complete or partial remission through the most recent platinum-based chemotherapy treatment. In the study, patients received Rubraca (600 mg, 2 times a day) or a placebo in a 2:1 ratio.
data show that the study successfully reached the main endpoint: the Rubraca treatment group had significantly longer progression-free survival (PFS) (10.8 months vs 5.4 months) than the placebo group, and was independent of BRCA status. Rubraca also significantly extended PFS (16.6 months vs 5.4 months) compared to placebo in patients with BRCA mutations in harmful reproductive systems or so system cells. The safety data in this study are consistent with previous clinical studies.
Rubraca's active pharmaceutical ingredient, rucaparib, is an oral, small molecule polyADP UC polymerase (PARP) inhibitor that targets the suppression of PARP1, PARP2, and PARP3. Rucaparib can use defects in DNA repair pathways to kill cancer cells first, a pattern that gives the drug the potential to treat a wide range of types of tumors with DNA repair defects. PARP is associated with a wide range of tumor types, especially breast and ovarian cancer. Currently, Clovis is developing rucaparib as a single drug therapy and in combination with other anticancer agents for the treatment of a variety of types of tumors, including ovarian cancer, metastatic degenerative prostate cancer, and bladder cancer.
In the U.S., Rubraca was first approved by the FDA in December 2016 for treatment in adult patients with ovarian epithelial, fallopian or primary peritum cancer who have received 2 or more rounds of chemotherapy in the past and carry harmful BRCA mutations (reproductive and/or soda cells). In April, the FDA further approved Rubraca's maintenance treatment for adults with relapsed ovarian epithelitis, fallopian tube cancer, or primary peritometrial cancer who received full or partial remission after receiving platinum-containing chemotherapy, while changing Rubraca's first acclimaation from accelerated approval to formal approval.
In the European Union, Rubraca was approved at the end of May this year for the treatment of adult patients with platinum sensitivity, relapse or progression, BRCA mutations (reproductive or somatic cells), high-level epitherial ovaries, fallopian tubes and primary peritina cancer.
October, Clovis published positive data on TRITON2, a phase II clinical study of Rubraca's treatment of prostate cancer, at the 2018 Meeting of the European Association of Oncology (ESMO2018) in Munich, Germany. The study was conducted in patients with metastatic degenerative degenerative prostate cancer (mCRPC) with BRCA gene changes, including reproductive or soytic cells.preliminary data released at the
conference showed that in 25 patients with RECIST/PCWG3 assessable carrying a BRCA1/2 gene change, the objective remission rate (ORR) of Rubraca therapy was 44% (n-11/25), and the medium remission duration of these patients had not yet been reached. In addition, in 45 patients with a PSA response with a BRCA1/2 gene change, rubraca's prostate cancer antigen (PSA) response rate was 51.1% (n=23/45).
Based on this finding, the FDA has granted Rubraca a breakthrough drug qualification (BTD) for single-drug therapy for patients with BRCA1/2 mutation mCRPC, specifically for BRCA1/2 mutant mCRPC patients who have previously received at least one androgen-receiving (AR) target therapy and yewtan chemotherapy. (Bio Valley)