Daily Archives: November 17, 2022

Mirvetuximab soravtansine-gynx is granted accelerated approval for FRĪ± positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer

November 17th, 2022 Ovarian Cancer

November 2022: For adult patients who have had one to three prior systemic treatment regimens and have folate receptor alpha (FR) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, the Food and Drug Ad.... Read More

Tremelimumab is approved by FDA

Tremelimumab is approved by FDA in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer

November 17th, 2022 Lung cancer

November 2022: The combination of tremelimumab (Imjudo, AstraZeneca Pharmaceuticals), durvalumab (Imfinzi, AstraZeneca Pharmaceuticals), and platinum-based chemotherapy was approved by the Food and Drug Administration for adult patients with met.... Read More

Brentuximab vedotin

Brentuximab vedotin is approved by FDA in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma

November 17th, 2022 Lymphoma

November 2022: The combination of doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide with brentuximab vedotin (Adcetris, Seagen, Inc.) has been approved by the Food and Drug Administration for use in children and young adults .... Read More

Cemiplimab-rwlc is approved by FDA in combination with platinum-based chemotherapy for non-small cell lung cancer

November 17th, 2022 Lung cancer

November 2022: The combination of cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) and platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 abnormalities has been ap.... Read More

Teclistamab-cqyv tecvayli

Teclistamab-cqyv is approved by FDA for relapsed or refractory multiple myeloma

November 17th, 2022 Myeloma

November 2022: The first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), was given accelerated approval by the Food and Drug Administration for adult patients with rela.... Read More

Tremelimumab

Tremelimumab is approved by FDA in combination with durvalumab for unresectable hepatocellular carcinoma

November 17th, 2022 Liver cancer

November 2022: The Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC). Efficacy was evaluated in HIMALAYA .... Read More

Cccelerated approval is granted by FDA to futibatinib for cholangiocarcinoma

November 17th, 2022 Cholangiocarcinoma

November 2022: The Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho Oncology, Inc.) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma .... Read More

Selpercatinib is approved by FDA for locally advanced or metastatic RET fusion-positive solid tumors

November 17th, 2022 Cancer

November 2022: Selpercatinib (Retevmo, Eli Lilly and Company) received accelerated approval from the Food and Drug Administration to treat adult patients with RET-fused solid tumours that are locally or metastatically advanced, have progressed o.... Read More

Sodium thiosulfate is approved by FDA to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors

November 17th, 2022 Cancer

November 2022: In children aged one month and older with localised, non-metastatic solid tumours, the Food and Drug Administration has approved sodium thiosulfate (Pedmark, Fennec Pharmaceuticals Inc.) to lower the risk of ototoxicity associated.... Read More

Durvalumab is approved for locally advanced or metastatic biliary tract cancer

November 17th, 2022 Cancer

November 2022: For adult patients with locally advanced or metastatic biliary tract cancer, the Food and Drug Administration has approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin (BTC).The effect.... Read More