Clarion Blog

In 2018, the biopharma industry made groundbreaking advances in oncology with 44 drug approvals in the US. “The pace of progress in cancer treatment is extraordinary and is the result of our industry and research community pushing forward on all fronts,” observes Dennis Chang, principal at Clarion. Below we highlight several of these approvals, encompassing multiple “firsts” and a range of diverse new treatments.

Exciting new “firsts” included:

• First tissue-agnostic targeted therapy: Loxo/Bayer’s Vitrakvi was approved for any solid tumor with NTRK gene fusions. Previously, Merck’s Keytruda was the first immunotherapy with a tissue-agnostic indication
• First PARP inhibitors for breast cancer: AstraZeneca’s Lynparza, after proven benefit in ovarian cancer, was approved in 2018 for BRCA-mutant breast cancer, followed later in the year by Pfizer’s Talzenna
• First approved treatments for 4 rare malignancies: Elzonristm (StemLine) was the first treatment approved for BPDCN, Gamifant (Novimmune) the first for HLH, Libtayo (Sanofi/Regeneron) the first for metastatic cutaneous SCC, and Tafinlar + Mekinist (Novartis) the first for BRAF-mutant anaplastic thyroid cancer
• First US biosimilar for Rituxan: After years on the European market, Celltrion and Teva’s Truxima finally became the first rituximab biosimilar to be approved in the US, for B-cell non-Hodgkin lymphoma. At least 6 additional rituximab biosimilars are in US clinical development

Sources: 1) Analysis by Natalie Thovmasian; 2) FDA; 3) Regeneron press release, 28 Sep 2018; 4) Citeline PharmaProjects; 5) Product labels

Among last year’s oncology approvals:

• Novartis had the most FDA approvals in 2018 including first-in-class radiopharmaceutical Lutathera, the first approved treatment for anaplastic thyroid cancer, Tafinlar + Mekinist, and other indication expansions
• Pfizer led the way in NMEs with SMO inhibitor Daurismo for AML, ALK inhibitor Lorbrena and EGFR inhibitor Vizimpro for NSCLC, and PARP inhibitor Talzenna for breast cancer
• AZ also breaks new ground: All 3 approvals were “firsts”: Imfinzi was the 1^st immunotherapy for Stage 3 NSCLC, Lynparza was the 1^st PARP inhibitor for breast cancer, and Lumoxiti was the 1^st anti-CD22
• Merck & BMS continue to expand their I-O empires: All their 2018 approvals were for Keytruda or Opdivo
• Seattle Genetics stands tall with its 2 Adcetris approvals, more than many top-20 pharma companies, and more than any other non-top-20 company

Sources: 1) Analysis by Natalie Thovmasian; 2) Drugs@FDA, https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm; 3) Citeline PharmaProjects; 4) FDA product labels

• NSCLC receives new, earlier treatments including 4 for frontline metastatic disease and 1 for stage 3
• Tissue-agnostic treatment #2: Vitrakvi became the first targeted therapy with a tissue-agnostic approval; Keytruda in 2017 became the first immunotherapy with a tissue-agnostic approval
• AML sees another banner year: 4 approvals, matching 2017; the last FDA approval prior to 2017 was in 2000
• Therapies emerge for previously neglected cancers including Sanofi/Regeneron’s Libtayo for cutaneous squamous cell carcinoma, Novartis’s Tafinlar+Mekinist for BRAF-mutant anaplastic thyroid cancer, AstraZeneca’s Lumoxiti for hairy cell leukemia, and the first treatments for BPDCN and HLH

Sources: 1) Analysis by Natalie Thovmasian; 2) Drugs@FDA, https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm; 3) Citeline PharmaProjects; 4) FDA product labels

In 2018, the biopharma industry made groundbreaking advances in oncology with 44 drug approvals in the US. “The pace of progress in cancer treatment is extraordinary and is the result of our industry and research community pushing forward on all fronts,” observes Dennis Chang, principal at Clarion. Below we highlight several of these approvals, encompassing multiple “firsts” and a range of diverse new treatments.

Exciting new “firsts” included:

• First tissue-agnostic targeted therapy: Loxo/Bayer’s Vitrakvi was approved for any solid tumor with NTRK gene fusions. Previously, Merck’s Keytruda was the first immunotherapy with a tissue-agnostic indication
• First PARP inhibitors for breast cancer: AstraZeneca’s Lynparza, after proven benefit in ovarian cancer, was approved in 2018 for BRCA-mutant breast cancer, followed later in the year by Pfizer’s Talzenna
• First approved treatments for 4 rare malignancies: Elzonristm (StemLine) was the first treatment approved for BPDCN, Gamifant (Novimmune) the first for HLH, Libtayo (Sanofi/Regeneron) the first for metastatic cutaneous SCC, and Tafinlar + Mekinist (Novartis) the first for BRAF-mutant anaplastic thyroid cancer
• First US biosimilar for Rituxan: After years on the European market, Celltrion and Teva’s Truxima finally became the first rituximab biosimilar to be approved in the US, for B-cell non-Hodgkin lymphoma. At least 6 additional rituximab biosimilars are in US clinical development

Sources: 1) Analysis by Natalie Thovmasian; 2) FDA; 3) Regeneron press release, 28 Sep 2018; 4) Citeline PharmaProjects; 5) Product labels

Among last year’s oncology approvals:

• Novartis had the most FDA approvals in 2018 including first-in-class radiopharmaceutical Lutathera, the first approved treatment for anaplastic thyroid cancer, Tafinlar + Mekinist, and other indication expansions
• Pfizer led the way in NMEs with SMO inhibitor Daurismo for AML, ALK inhibitor Lorbrena and EGFR inhibitor Vizimpro for NSCLC, and PARP inhibitor Talzenna for breast cancer
• AZ also breaks new ground: All 3 approvals were “firsts”: Imfinzi was the 1^st immunotherapy for Stage 3 NSCLC, Lynparza was the 1^st PARP inhibitor for breast cancer, and Lumoxiti was the 1^st anti-CD22
• Merck & BMS continue to expand their I-O empires: All their 2018 approvals were for Keytruda or Opdivo
• Seattle Genetics stands tall with its 2 Adcetris approvals, more than many top-20 pharma companies, and more than any other non-top-20 company

Sources: 1) Analysis by Natalie Thovmasian; 2) Drugs@FDA, https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm; 3) Citeline PharmaProjects; 4) FDA product labels

• NSCLC receives new, earlier treatments including 4 for frontline metastatic disease and 1 for stage 3
• Tissue-agnostic treatment #2: Vitrakvi became the first targeted therapy with a tissue-agnostic approval; Keytruda in 2017 became the first immunotherapy with a tissue-agnostic approval
• AML sees another banner year: 4 approvals, matching 2017; the last FDA approval prior to 2017 was in 2000
• Therapies emerge for previously neglected cancers including Sanofi/Regeneron’s Libtayo for cutaneous squamous cell carcinoma, Novartis’s Tafinlar+Mekinist for BRAF-mutant anaplastic thyroid cancer, AstraZeneca’s Lumoxiti for hairy cell leukemia, and the first treatments for BPDCN and HLH

Sources: 1) Analysis by Natalie Thovmasian; 2) Drugs@FDA, https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm; 3) Citeline PharmaProjects; 4) FDA product labels

If you are interested in learning more about Clarion’s work in oncology, please see the “Our Work” section of our website.