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Genentech announces FDA Approval of ROZLYTREK

Genentech is excited to share the news of a new FDA approval. ROZLYTREK™ (entrectinib) is now FDA approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. ROZLYTREK is also FDA approved for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that: have […]

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FDA grants approval for POLIVY™

On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval for POLIVY™ (polatuzumab vedotin-piiq) in combination with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least 2 prior therapies. POLIVY Access Solutions is your resource for access and reimbursement support after POLIVY is prescribed. We can help your patients and practice by providing: […]

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Merck announces new FDA approval for KEYTRUDA

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 [combined positive score (CPS) ≥10] as determined by an FDA-approved test, with disease progression after one or more prior lines of […]

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US Food and Drug Administration approves INREBIC® for Treatment

INREBIC® (fedratinib) capsules, a product from Celgene, is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). INDICATION INREBIC® (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). IMPORTANT SAFETY […]

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KEYTRUDA approved by FDA for first-line treatment of patients with HNSCC

AstraZeneca is pleased to announce that IMFINZI® (durvalumab) injection has been assigned…

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(FDA) approves a label change for ADCETRIS® (brentuximab vedotin) for injection, for intravenous use.

On November 16, 2018, the U.S. Food and Drug Administration (FDA) approved a label change for ADCETRIS® (brentuximab vedotin) for injection, for intravenous use. The new indication is as follows: Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not […]

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FDA-Approved Indication for KEYTRUDA® (pembrolizumab) for the Treatment of Adult Patients With Hepatocellular Carcinoma (HCC)

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with HCC who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description […]

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FDA-Approved Indication for KEYTRUDA® (pembrolizumab) Announced

Merck is pleased to announce that KEYTRUDA in combination with carboplatin and either paclitaxel or nab-paclitaxel has been approved by the FDA for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA is also indicated in combination with pemetrexed and platinum chemotherapy for the First-line treatment of patients with metastatic nonsquamous NSCLC, with no […]

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AstraZeneca announces FDA approval of LUMOXITITM for the treatment of certain adult patients

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has approved LUMOXITITM (moxetumomab pasudotox-tdfk), a first-in-class CD22-directed cytotoxin, for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with […]

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Opdivo® (nivolumab) Receives FDA Approval for Certain Patients with Previously Treated Small Cell Lung Cancer

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer (BMS) Aug 17, 2018 – Bristol-Myers Squibb Company today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment […]

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