FDA Approvals, News & Updates

Keytruda Approved for Patients with Previously Treated Metastatic Small-Cell Lung Cancer

Lung cancer is the second most frequently diagnosed malignancy in both men and women (following prostate and breast cancer, respectively), and the leading cause of cancer deaths overall. Non–small-cell lung cancer (NSCLC) is the most common type, with the more aggressive small-cell lung cancer (SCLC) making up approximately 10% to [ Read More ]

First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL

On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval to the novel antibody-drug conjugate polatuzumab vedotin-piiq (Polivy; Genentech) in combination with bendamustine plus rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after [ Read More ]

FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer

On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an [ Read More ]

Ivosidenib Now FDA-Approved as First-Line Treatment for AML with IDH1 Mutation

On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have [ Read More ]

FDA Approves Pembrolizumab plus Axitinib for Advanced Renal-Cell Carcinoma

On April 19, 2019, the US Food and Drug Administration (FDA) approved a combination of pembrolizumab (Keytruda; Merck) plus axitinib (Inlyta; Pfizer) for the first-line treatment of patients with advanced renal-cell carcinoma (RCC), making it the first immunotherapy combination regimen approved for patients with this disease. This application was granted [ Read More ]

April 16, 2019 – FDA Approvals, News & Updates

In This Article FDA Approves Keytruda for First-Line Treatment of Non–Small-Cell Lung Cancer (TPS ≥1%) FDA Advises Women to Avoid Pregnancy for Only 2 Months After Final Dose of Soltamox FDA Approves Keytruda for First-Line Treatment of Non–Small-Cell Lung Cancer (TPS ≥1%) On April 11, 2019, the US Food and [ Read More ]

FDA Approves First Hormonal-Based Therapy for Men with Advanced or Metastatic Breast Cancer

On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based [ Read More ]

Proposed Landmark Policy Changes to Modernize Mammography and Raise Breast Density Awareness

On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services. Currently, under the Mammography Quality Standards Act, which [ Read More ]

FDA Approves Tecentriq plus Chemotherapy for First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer

For the second time this month, the FDA has given an approval to Genentech’s PD-L1 inhibitor, Tecentriq. On March 18, 2019, the FDA awarded the immunotherapy agent, Tecentriq (atezolizumab; Genentech), in combination with chemotherapy (carboplatin and etoposide), approval for the first-line treatment of adults with extensive-stage small-cell lung cancer (ES-SCLC). [ Read More ]

FDA Approves Tecentriq plus Abraxane—First Immunotherapy for PD-L1– Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

On March 8, 2019, the FDA granted accelerated approval to Genentech’s Tecentriq (atezolizumab), in combination with nab-paclitaxel (Abraxane), for the treatment of PD-L1–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This marks the first time an immunotherapy drug has been granted approval for the treatment of any form [ Read More ]

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