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Several months into the COVID-19 pandemic, this article takes a look back at how the launches of new oncology therapies have been impacted.
Ben Hohn, Judith Kulich, and Swarna Mehrotra co-authored this article with Matt Furlow.
Periodically, ZS assesses factors impacting oncology launches in the U.S. and globally. Biopharma companies anticipating launches of new oncology therapies over the course of 2020 can take learnings from launches that have occurred so far in 2020 and inform launch expectations and adaptations accordingly. Several months into the COVID-19 pandemic, we’ve taken a look back at how the pandemic has impacted launches of new oncology therapies (that is, new applications rather than supplementary applications), answering three critical questions along the way:
In short, it hasn’t, at least yet. The table below summarizes 2020 FDA approvals of new oncology therapies; no approvals have been delayed relative to expected PDUFA dates. In fact, the majority of approvals have been granted prior to expected PDUFA dates, in some cases coming even three to four months prior.
On the surface, the fact that the FDA has consistently delivered decisions on time or prior to stated PDUFA dates during the pandemic could be surprising, considering the effort devoted to advising developers of potential COVID-19 treatments and vaccines as well as a shift to virtual modes of collaboration. However, the FDA Oncology Center of Excellence’s Richard Pazdur has firmly expressed the FDA’s commitment to cancer patients: “We’re here for you. We’re pushing this forward. We haven’t lost our momentum or our dedication to cancer patients." 1 Innovative programs developed by the FDA like Real Time Oncology Review have also helped make review processes more efficient.
For new oncology therapies that are expecting decisions from the FDA in Q3 and Q4 of 2020, it is possible that delays due to COVID-19 may start to occur, especially if evaluation of submissions requires in-person visits to manufacturing sites outside of the U.S. (or other activities impacted by the pandemic). From what ZS has observed from approvals thus far in 2020, however, decisions regarding therapies addressing relapsed unresectable/metastatic and/or biomarker-directed indications likely will continue to come in advance of PDUFA dates. In contrast, cell and gene therapy submissions routed through CBER may see delays as effort is focused on SARS-CoV-2 vaccines.
While there have been notable examples of non-oncology U.S. launches delayed due to the COVID-19 pandemic such as Zeposia, Palforzia, Xiaflex and Ongentys, new oncology therapy launch timings have largely followed FDA approvals. For example, Eli Lilly launched Retevmo for RET+ NSCLC and thyroid cancer shortly after FDA approval with a virtual rollout while sales teams were grounded. When asked about the decision to launch, Anne White, president of Lilly Oncology, said: “Given the critical nature of the treatment, the company will launch the drug immediately despite the challenging commercial dynamics.” 2 Based on ZS analysis, other 2020 new oncology therapy approvals have taken similarly urgent, virtual approaches. Sarclisa’s launch in multiple myeloma may be a slight exception 3, but Sarclisa’s HCP website does have functionality to request contact from a representative.
With the COVID-19 pandemic far from resolved in the U.S. and new hot spots emerging in specific geographies, new and ongoing oncology launches may require tailoring to needs and restrictions of specific geographies (even when considering virtual approaches). Esperion is one non-oncology example. The company trained its field team on digital tools and ways of marketing and reducing virtual calls in geographies more impacted by COVID-19.
Both patient and provider preferences have evolved over the course of the COVID-19 pandemic.
ZS-commissioned research with patients and providers also suggests that a “return to normal” is not expected until Q2 2021 at the earliest, indicating that these preferences will persist for some time. Based on these evolving preferences and 2020 launches and with input from ZS practice leaders, we’ve identified three over-arching themes for adapting launch strategy and tactics for new oncology therapies:
From examining the new 2020 oncology therapy approvals and launches, the lessons are clear: Be prepared to act quickly, adapt to a virtual world and customize to the specific needs of patients and providers.
Matt Furlow is a manager within ZS’s oncology vertical. Ben Hohn and Judith Kulich are principals at ZS and leaders of the Pipeline & Launch Strategy practice. Swarna Mehrotra is a ZS consultant.