Investigational Therapy Significantly Improves Survival in Patients with Prostate Cancer
June 4th 2021The addition of an investigational therapy to standard-of-care treatment was associated with a median overall survival of 15.3 months in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer.
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Zytiga and Prednisone Plus Erleada Reduces Risk of Disease Progression in Prostate Cancer Subtype
February 12th 2021The combination of Erleada, Zytiga and the steroid prednisone was associated with a trend toward better survival outcomes in certain patients with chemotherapy-naive metastatic castration-resistant prostate cancer.
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FDA Grants Polivy Accelerated Approval for DLBCL
June 10th 2019The FDA has granted an accelerated approval to Polivy for use in combination with bendamustine and Rituxan for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma who have received at least two prior therapies.
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FDA Approves Piqray to Treat Breast Cancer
May 25th 2019The Food and Drug Administration has approved the PI3K inhibitor Piqray (alpelisib) for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
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FDA Grants Priority Review to Revlimid Plus Rituxan for Indolent Non-Hodgkin Lymphoma
February 27th 2019The Food and Drug Administration granted a priority review to Revlimid (lenalidomide) plus Rituxan (rituximab) for the treatment of patients with previously treated follicular lymphoma and marginal zone lymphoma.
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Immunotherapy Regimen Granted Priority Review in Small Cell Lung Cancer
December 5th 2018The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for Tecentriq (atezolizumab) for use in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
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FDA Approves Larotrectinib for NTRK-Positive Cancers
November 27th 2018The FDA has granted an accelerated approval to larotrectinib for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
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FDA Grants Lynparza Priority Review for Frontline Maintenance in Ovarian Cancer
November 12th 2018The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for Lynparza (olaparib) tablets for use as a maintenance therapy in patients with newly-diagnosed, BRCA-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.
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FDA Approves Empliciti Regimen to Treat Relapsed or Refractory Myeloma
November 7th 2018The Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for use in combination with Pomalyst (pomalidomide) and low-dose dexamethasone, also known as EPd, for the treatment of patients with relapsed/refractory multiple myeloma following two or more prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor.
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Drug Duo Granted Priority Review for CLL Treatment
October 17th 2018The FDA has granted a priority designation to a supplemental new drug application (sNDA) for Imbruvica (ibrutinib) for use in combination with Gazyva (obinutuzumab) for the frontline treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
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FDA Approves Vizimpro for EGFR-Positive Lung Cancer
September 28th 2018The Food and Drug Administration (FDA) has approved Vizimpro (dacomitinib) for the frontline treatment of patients with metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 L858R substitution mutations, according to Pfizer, the manufacturer of the pan-human EGFR tyrosine kinase inhibitor (TKI).
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FDA Grants Empliciti Combination a Priority Review for Myeloma Treatment
August 23rd 2018The FDA has granted a priority review to a supplemental biologics license application (sBLA) for Empliciti (elotuzumab) for use in combination with Pomalyst (pomalidomide) and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma following two or more prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor (PI).
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FDA Grants Full Approval for Keytruda Combination in Lung Cancer
August 20th 2018The Food and Drug Administration (FDA) has granted a full approval to frontline Keytruda (pembrolizumab) for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), based on findings from the phase 3 KEYNOTE-189 trial.
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Triplet Gets Breakthrough Therapy Designation in Colorectal Cancer
August 8th 2018The FDA has granted a breakthrough therapy designation to the combination of the BRAF inhibitor Braftovi (encorafenib), the MEK inhibitor Mektovi (binimetinib), and the EGFR inhibitor Erbitux (cetuximab) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC) following one or two prior lines of treatment in the metastatic setting.
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Drug Duo Granted Breakthrough Status to Treat Endometrial Cancer
August 2nd 2018The FDA has granted a breakthrough therapy designation to the combination of Lenvima (lenvatinib) and Keytruda (pembrolizumab) for the treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient mismatch repair endometrial carcinoma who have progressed after at least one prior systemic therapy.
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FDA Approves Azedra for Rare Neuroendocrine Tumors
July 31st 2018The Food and Drug Administration (FDA) has approved Azedra (iobenguane I-131) for adult and pediatric patients aged 12 years or older with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy.
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FDA Approves Drug Duo for BRAF-Positive Melanoma
June 27th 2018The FDA has approved the combination of the BRAF inhibitor Braftovi (encorafenib) and the MEK inhibitor Mektovi (binimetinib) for the treatment of patients with BRAF-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test.
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Keytruda Granted sBLA for Melanoma Treatment
June 25th 2018The FDA has accepted a supplemental biologics license application (sBLA) for the use of Keytruda (pembrolizumab) as an adjuvant treatment for patients with resected, high-risk stage 3 melanoma, according to Merck (MSD), the manufacturer of the PD-1 inhibitor.
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Drug Duo Granted Priority Review to Treat Waldenstrom Macroglobulinemia
June 25th 2018The FDA has granted a priority review to a supplemental new drug application (sNDA) Imbruvica (ibrutinib) for use in combination with Rituxan (rituximab) as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.
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