New Phase 2 Data Show Treatment with TREMFYA (Guselkumab) Improved Psoriatic Arthritis Symptoms Through One year
November 7, 2017
Janssen Research & Development, LLC (Janssen) announced today longer-term results from a Phase 2 study investigating TREMFYA® (guselkumab), the first selective anti-interleukin (IL)-23 monoclonal antibody to show positive results in the treatment of active psoriatic arthritis. According to findings presented at the 2017 ACR/ARHP Annual Meeting, more than 70 percent of patients receiving TREMFYA® 100 mg subcutaneous injections achieved at least a 20 percent improvement in signs and symptoms of disease (ACR 20) using observed data at week 56.
Novartis announces study data demonstrating Cosentyx® reduced signs and symptoms of psoriatic arthritis while inhibiting progression of joint structural damage
November 7, 2017
Novartis has announced results from the FUTURE 5 study showing Cosentyx® (secukinumab) reduced the signs and symptoms of psoriatic arthritis (PsA) while significantly inhibiting the progression of joint structural damage in PsA patients compared to placebo at 24 weeks.
Opdivo Plus Yervoy Combination Delivered Overall Survival Benefit Across PD-L1 Expression Levels in Intermediate- and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
November 7, 2017
Bristol-Myers Squibb Company has announced results from a new exploratory analysis of the phase 3 CheckMate -214 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus the standard of care, sunitinib, in intermediate- and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). In an exploratory analysis of PD-L1 expression subgroups, an overall survival (OS) advantage was seen with the Opdivo plus Yervoy combination over sunitinib in both the PD-L1 expression level <1% [HR= 0.73, (CI: 95% 0.56 to 0.96)] and ?1% subgroups [HR= 0.45 (CI: 95% 0.29 to 0.71)]. The median overall survival (OS) was not reached for the Opdivo plus Yervoy combination or sunitinib for those with PD-L1 levels < 1%, and for patients with PD-L1 expression levels ?1%, the median OS was not reached for the combination and was 19.6 months for sunitinib. The safety profile of Opdivo plus Yervoy was consistent with that of previous reports.
Novartis reports positive results from Phase III trial of Kisqali® (ribociclib) combination therapy in premenopausal women with HR+/HER2- advanced or metastatic breast cancer
November 8, 2017
Novartis has announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali® (ribociclib) in advanced or metastatic breast cancer. The MONALEESA-7 trial met its primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.
Seattle Genetics Announces FDA Approval of ADCETRIS® (Brentuximab Vedotin) for Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) and CD30-Expressing Mycosis Fungoides (MF)
November 9, 2017
Seattle Genetics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Primary cutaneous ALCL and MF are the most common subtypes of cutaneous T-cell lymphoma (CTCL). The approval is based on data from the phase 3 ALCANZA trial and two phase 2 investigator-sponsored trials.
Merck Receives FDA Approval of PREVYMIS™ (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients
November 9, 2017
Merck & Co., Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved PREVYMIS™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. PREVYMIS is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
Encouraging Response Observed with Opdivo (nivolumab) Plus Investigational IDO1 Inhibitor, BMS-986205, in Heavily Pre-Treated Patients with Advanced Cancers in Phase 1/2a Study CA017-003
November 10, 2017
Bristol-Myers Squibb Company has announced updated results for Opdivo (nivolumab) plus BMS-986205, a selective, once-daily oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor from the ongoing Phase 1/2a dose escalation and expansion study, CA017-003. In the dose escalation phase, the maximum tolerated dose (primary endpoint) of BMS-986205 in combination with Opdivo was 200 mg. Based on safety and pharmacodynamic data, the recommended dose for further study was determined to be 100 mg. In the dose expansion phase, findings for anti-tumor activity (primary endpoint) were reported in two cohorts – heavily pre-treated bladder (n=25) and cervical cancer patients (n=22). In the bladder cancer cohort, the objective response rate (ORR) and disease control rate (DCR) were 32% and 44%, respectively. In the cervical cancer cohort, the ORR was 14% and DCR was 64%.
U.S. Food and Drug Administration Expands Approval of Sprycel® (dasatinib) to Include Treatment of Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase
November 10, 2017
Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel ® (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). This approval for Sprycel in pediatric patients with Ph+ CML in chronic phase was granted under priority review, and the indication received orphan drug designation from the FDA. The safety and efficacy of Sprycel in pediatric patients was evaluated in two pediatric studies of 97 patients with CP-CML: an open-label, non-randomized, dose-ranging trial (NCT00306202) and an open-label, non-randomized, single-arm trial (NCT00777036). Among the 97 patients in the two studies, 51 patients (exclusively from the single-arm trial) had newly diagnosed CP-CML, and 46 patients (17 from the dose-ranging trial and 29 from the single-arm trial) were resistant or intolerant to previous treatment with imatinib.
Amgen And Allergan Receive Positive CHMP Opinion for ABP 215 (Biosimilar Bevacizumab) For the Treatment of Certain Types of Cancer
November 10, 2017
Amgen and Allergan plc. have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 215, a biosimilar to Avastin®(bevacizumab). ABP 215 has been recommended for approval for the treatment of certain types of cancer, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC; in combination with interferon alfa-2a for advanced and/or metastatic renal cell cancer; in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin for advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix.
First Data for NKTR-214 in Combination with OPDIVO® (nivolumab) for Patients with Stage IV Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers, Including Patients with PD-L1 Negative Status
November 11, 2017
Nektar Therapeutics and Bristol-Myers Squibb have announced the first presentation of data from the PIVOT-02 Phase 1/2 Study, which is designed to evaluate the combination of Bristol-Myers Squibb’s Opdivo (nivolumab) with Nektar’s investigational medicine, NKTR-214. The initial results presented at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting reported both safety and efficacy data for patients enrolled in the dose-escalation phase of the trial. The initial findings revealed the potential benefit of the combination of Opdivo and NKTR-214 across several tumor types. NKTR-214 preferentially binds to the CD122 receptor on the surface of cancer-fighting immune cells in order to stimulate their proliferation
New Novartis Entresto® real world evidence data shows beneficial impact on quality of life in people living with heart failure
November 12, 2017
Novartis has announced new results from a real-world database study of patients in Germany prescribed Entresto® (sacubitril/valsartan) for heart failure with reduced ejection fraction (HFrEF). The findings further substantiate the beneficial effect of Entresto on heart failure symptoms and patients’ quality of life observed in the PARADIGM-HF study and in other real-world cohorts.Top Pharma News of the Week last edit: 2017-11-14T18:40:15+00:00 da