Resources for For Clinicians

Ado-trastuzumab emtansine (Kadcyla®)

• Received prior therapy for metastatic disease, or
• Developed disease recurrence during or within six months of completing adjuvant therapy

Belantamab mafodotin (Blenrep™)

• Belantamab mafodotin (Blenrep™)
• Blenrep REMS (Risk Evaluation and Mitigation Strategy)
• Access & reimbursement enrollment form (United States Only)

* In November 2022, after an update from the phase 3 DREAMM-3 study the use of belantamab monotherapy for previously treated patients with relapsed or refractory multiple myeloma was pulled from US market authorization by request of the US Food and Drug Administration (FDA).

Brentuximab Vedotin (Adcetris®)

• Classical Hodgkin lymphoma (HL) after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
• Classical HL at high risk of relapse or progression as post auto-HSCT consolidation treatment.
• Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
• The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Additional information:

• Brentuximab Vedotin
• Brentuximab Vedotin (Updates)

Enfortumab Vedotin-ejfv (Padcev™)

Additional Information

• Enfortumab vedotin-ejfv (Padcev™) / HCP
• Patient Assistant Program

Fam-trastuzumab deruxtecan-nxki (Enhertu®)

• Fam-trastuzumab deruxtecan-nxki (Enhertu®) – Patient Information
• Fam-trastuzumab deruxtecan-nxki (Enhertu®) – HCP

Gemtuzumab Ozogamicin (Mylotarg®)

Second: 2017

• Gemtuzumab Ozogamicin

Inotuzumab Ozogamicin (Besponsa®)

• Inotuzumab Ozogamicin

Loncastuximab tesirine-lpyl (Zynlonta^®)

• Loncastuximab tesirine-lpyl (Zynlonta^®)

Mirvetuximab Soravtansine-gynx (Elahere®)

Mirvetuximab soravtansine (Elahere®; previously known as IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent to kill the targeted cancer cells.

The US Food and Drug Administration (FDA) granted accelerated approval for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Mirvetuximab soravtansine was approved under FDA’s accelerated approval program based on objective response rate (ORR) and duration of response (DOR) data from the pivotal SORAYA trial. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Mirvetuximab soravtansine is a first-in-class ADC directed against FRα, a cell-surface protein highly expressed in ovarian cancer, and is the first FDA approved ADC for platinum-resistant disease.
History In June 2018, the FDA granted mirvetuximab Fast Track designation for the treatment of patients with medium to high FRα-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy. This designation is intended to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions.

In December 2019, the Company (ImmunoGen) announced that FDA advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab. Based on this guidance, the Company initiated SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with FRα-high platinum-resistant ovarian cancer who have been previously treated with bevacizumab (Avastin®; Genentech/Roche). Positive top-line data for SORAYA was announced in November 2021.

Confirmation studies ImmunoGen is concurrently enrolling MIRASOL, the Phase 3 randomized confirmatory study of mirvetuximab in patients with FRα-high platinum-resistant ovarian cancer who have been treated with up to three prior regimens. Mirvetuximab monotherapy is also being studied in later line platinum-sensitive ovarian cancer and in combination in both platinum-resistant and platinum-sensitive disease.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• Mirvetuximab soravtansine (Elahere®)

Polatuzumab Vedotin-piiq (Polivy™)

Sacituzumab Govitecan-hziy (Trodelvy™

• Sacituzumab Govitecan-hziy (Trodelvy™)

Tisotumab vedotin-tftv (Tivdak® )

• Tisotumab vedotin-tftv (Tivdak® )