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Rakuten Medical’s Sakigake-Designated Photoimmunotherapy Up for MHLW Panel Review on Sept.4
August 25, 2020
Rakuten Medical’s sakigake-designated antibody drug conjugate (ADC) (cetuximab sarotalocan sodium), based on its photoimmunotherapy technology platform, as well as a host of other drugs, will come up for discussion by a key health ministry advisory committee on September 4. A thumbs-up from the panel will put them in line for approval as early as September.
The Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) Second Committee on Drugs, a de-facto decision-making body for marketing approval, will review at its virtual meeting whether to recommend approval for the product, also known as ASP-1929, for the treatment of recurrent head and neck cancer.
The product is composed of EGFR-targeting cetuximab linked to the light-sensitive dye IR700. IR700, which reacts to non-thermal red light, is transported to cancer cells by cetuximab and later activated by laser exposure to necrotize cancer cells by destroying their cell membranes. The med was designated for the sakigake fast-track review pathway in April 2019 and filed for regulatory approval in March this year. In May it was designated for the conditional, early approval system.
Rakuten Medical also submitted in March an application for a laser device to be used in combination with the ADC to irradiate IR700.
Takeda’s Oral PARP Inhibitor, Gilead’s JAK1 Inhibitor
The panel will also review Takeda Pharmaceutical’s oral PARP inhibitor niraparib for the treatment of ovarian cancer. Takeda licensed the drug, marketed in the US and Europe under the brand name of Zejula, from US-based Tesaro (currently GlaxoSmithKline’s subsidiary) in July 2017. In the PARP inhibitor class, AstraZeneca’s Lynparza (olaparib) is already available.
Gilead Sciences’ oral selective JAK1 inhibitor filgotinib will also be discussed for its use in the treatment of rheumatoid arthritis (RA). Gilead struck a deal in December last year with Eisai for the co-commercialization of the drug in Japan. After approval, Eisai will be responsible for its distribution in Japan, while the companies will jointly promote the drug. The med is also under development for ulcerative colitis, Crohn’s disease, and psoriatic arthritis. It will be Japan’s fifth JAK inhibitor for the treatment of RA.
Enhertu for Sakigake-Designated Gastric Cancer Indication
Meanwhile, at the meeting, the Ministry of Health, Labor and Welfare (MHLW) will report its plan to approve new indications or dosages for six products. A new indication of “HER2 positive gastric cancer” will be added to Daiichi Sankyo’s HER2-targeting ADC Enhertu (trastuzumab deruxtecan), which is expected to be the company’s blockbuster hopeful. It hit the Japan market in May as a third-line therapy in HER2 positive breast cancer. Regarding gastric cancer, it was granted sakigake designation in March 2018, and filed for approval in May this year. If approved, it will be the drug’s second indication. The agent is also under development for different tumor types including non-small cell lung cancer (NSCLC) and colorectal cancer.
Ono Pharmaceutical’s anti-PD-1 antibody Opdivo (nivolumab) will add a new dosage of 480 mg for its current indications (malignant melanoma, colorectal cancer, renal cell cancer, Hodgkin’s lymphoma, head and neck cancer, gastric cancer, malignant pleural mesothelioma, and esophageal cancer) to enable it to be administered at “a dose of 480 mg every four weeks via intravenous infusion.” Its current dosage is “240 mg once every two weeks.”
In addition, Opdivo in combination with Bristol Myers Squibb’s anti-CTLA-4 antibody Yervoy (ipilimumab) will also be allowed for use in microsatellite instability-high (MSI-High) colorectal cancer.
Chugai Pharmaceutical’s anti-PD-L1 antibody Tecentriq (atezolizumab) and anti-VEGF antibody Avastin (bevacizumab) will add a new dosage for a combination therapy for hepatocellular carcinoma, a new indication.
The MHLW will also approve an additional indication of non-radiographic axial spondyloarthritis and an additional dosage for Eli Lilly’s anti-human IL-17A monoclonal antibody Taltz (ixekizumab).
3 Orphan Candidates
Elsewhere, the Second Committee will also deliberate on whether to grant orphan designation for three APIs: Nobelpharma’s sargramostim (proposed indications: autoimmune alveolar proteinosis), BMS’s ipilimumab (malignant pleural mesothelioma), and Novartis Pharma’s midostaurin (FLT3-mutant acute myeloid leukemia).