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FDA approves label expansion for ALUNBRIG® (brigatinib)

Takeda Oncology has announced that the US Food and Drug Administration (FDA) has approved the label expansion for ALUNBRIG® (brigatinib) to include patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are tyrosine kinase inhibitor (TKI)-naive. ALUNBRIG is indicated for the treatment of adult patients with ALK+ metastatic NSCLC as detected by an […]

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US Food and Drug Administration (FDA) approves a new indication for LYNPARZA® (olaparib)

US Food and Drug Administration (FDA) approved a new indication for LYNPARZA® (olaparib), as a treatment option for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an […]

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New Indication approved by FDA for LYNPARZA® (olaparib)

Astra Zeneca announced that the US Food and Drug Administration (FDA) approved a new indication for LYNPARZA® (olaparib), in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy and whose cancer is associated with […]

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Novartis announces FDA approval of MET inhibitor Tabrecta™ for metastatic non-small cell lung cancer with METex14

Novartis announces FDA approval of MET inhibitor Tabrecta™ for metastatic non-small cell lung cancer with METex14 • Tabrecta (capmatinib, formerly INC280) is the first and only therapy approved by the FDA to specifically target metastatic NSCLC with a mutation that leads to MET exon 14 skipping (METex14)1 • ~4,000-5,000 patients are diagnosed with METex14 metastatic […]

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Seattle Genetics announces approval of TUKYSA by the U.S. Food and Drug Administration (FDA).

TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. We look forward to sharing the efficacy and safety data from the HER2CLIMB trial as […]

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U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy

Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.1 The approval is based on results […]

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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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