Tag Archives: Genentech

December 2020—Roche announced FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection fusion–positive non-small cell lung cancer as detected by an FDA-approved test. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations.

January 2020—Genentech announced positive data from the phase three IMpower110 study evaluating Tecentriq (atezolizumab) as a first-line monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine in advanced nonsquamous and squamous non-small cell lung cancer without ALK or EGFR mutations.

July 2019—Genentech announced results from the pivotal phase three CLL14 study in previously untreated chronic lymphocytic leukemia showing that Venclexta (venetoclax) plus Gazyva (obinutuzumab) met its primary endpoint of investigator-assessed progression-free survival.

May 2019—Genentech announced FDA approval of Tecentriq (atezolizumab) in combination with carboplatin and etoposide for the initial treatment of adults with extensive-stage small cell lung cancer.

April 2019—The Food and Drug Administration approved trastuzumab and hyaluronidase-oysk (Herceptin Hylecta, Genentech) for subcutaneous injection for the treatment of certain people with HER2-positive early breast cancer in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease.

March 25, 2019—Genentech announced FDA approval of Tecentriq (atezolizumab) in combination with carboplatin and etoposide for the initial treatment of adults with extensive-stage small cell lung cancer. “Extensive-stage small cell lung cancer is a highly aggressive form of lung cancer, which until now has seen limited treatment advances over the last 20 years,” Andrea Ferris, president and CEO of Lungevity ...

March 8, 2019–Genentech, a member of the Roche Group, today announced the FDA has granted accelerated approval to Tecentriq (atezolizumab) plus chemotherapy

January 2018—Genentech announced the FDA’s approval of Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors.

Jan. 3, 2018—Genentech announced Dec. 20 the FDA’s approval of Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence. People should receive the adjuvant Perjeta-based regimen for one year (up to 18 cycles). The FDA has also converted the previously granted accelerated approval of ...